Prosthetic capsular devices, systems, and methods

ABSTRACT

Prosthetic capsular devices (e.g., bag, bowl, housing, structure, cage, frame) include technology devices such as a computer, virtual reality device, display device, WiFi/internet access device, image receiving device, biometric sensor device, game device, image viewers or senders, GPSs, e-mail devices, combinations thereof, and/or the like. The technology devices can be used in combination with an intraocular lens. The output from the technology device(s) can be fed to the retina of the user to provide a visual image, can be otherwise connected to the user, and/or can be used to control the properties of the intraocular lens or of the prosthetic capsular device. Wearable technology that provides biometric data, such as blood glucose levels, body temperature, electrolyte balance, heart rate, EKG, EEG, intraocular pressure, sensing ciliary muscle contraction for accommodation stimulus, dynamic pupil change and retinal prostheses, combinations thereof, and the like can assist in technology-assisted health care functions.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application claims priority benefit of U.S. Provisional PatentApplication No. 62/014,432, filed Jun. 19, 2014, U.S. Provisional PatentApplication No. 62/114,227, filed Feb. 10, 2015, and U.S. ProvisionalPatent Application No. 62/168,557, filed May 29, 2015, each of which isincorporated herein by reference in its entirety. Any and allapplications for which a foreign or domestic priority claim isidentified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 C.F.R. § 1.57.

BACKGROUND

Technical Field

The present application relates to prosthetic capsular devices includingwearable electronic technology device(s), and methods for insertion intothe eye.

Description of the Art

Cataract surgery is one of the most successfully and most frequentlyperformed surgical procedures in the United States. Each year, millionsof people achieve a dramatic improvement in their visual function thanksto this procedure. With the increasing proportion of the U.S. populationreaching their retirement years, there is expected to be an almostdoubling of the demand for cataract surgery over the next twenty yearsfrom 3.3 million to over 6 million annually. In response to theincreased demand, more ophthalmologists may be trained and certified toperform cataract surgery, and each trained and certified ophthalmologistmay perform more cataract surgeries each year.

In addition to the increase in demand for cataract surgery,technological advances have increased patient expectations for thesurgery. The procedure takes a short amount of time to perform, andpatients expect quick recovery of visual function. Patients are alsoasking their ophthalmologist to give them the restoration of moreyouthful vision without glasses through the use multifocal intraocularlenses, presbyopia correcting lenses, toric lenses, and monovision, toname a few. Despite accurate preoperative measurements and excellentsurgical technique, the desired refractive outcome requires a dose ofgood fortune as there are numerous uncontrolled variables involved. Asmany as 20-50% of post-operative cataract patients may benefit fromglasses or follow-up refractive surgical enhancements to achieve theirdesired refractive endpoint. The reason for this high amount ofrefractive unpredictability is believed to be the final resting positionof the lens implant in the eye, mathematically expressed as theeffective lens position (ELP), which can be quite variable andunpredictable in the current state of cataract surgery. Recently,hundreds of millions of dollars have been invested into developinghighly sophisticated femtosecond laser systems that are able to moreprecisely control the size and shape of the capsulotomy and cornealincisions with the stated goal of lessening the variability of the ELPand thus aiding in better refractive outcomes. Unfortunately, theincreased precision of the femtosecond laser systems have not been ableto account for the major problem plaguing the variability of the ELP,which is the volumetric difference between the cataract, naturalcapsular bag, and intraocular lens implant (IOL).

A device and method that helps provide the desired refractive endpointin cataract surgery is described in PCT Published Patent Application No.WO 2013/126380, Wortz, published on Aug. 29, 2013, which is incorporatedherein by reference in its entirety.

All patents and other documents referred to in this application areincorporated by reference herein in their entirety.

SUMMARY

Over the past few years, there has been a major increase in the presenceof and reliance on small electronic devices, such as smartphones andrelated wearable technology, which can provide the user with functionssuch as internet access, computational ability, computer functionality,e-mail, games, and global positioning system (GPS) function. Some ofthese devices are being miniaturized and are sometimes worn on the body,such as Google Glass, Microsoft HoloLens, and other head-mounteddisplays. Additionally, wearable technology that provides biometric datasuch as blood glucose levels, electrolyte balance, heart rate,electrocardiogram (EKG), intraocular pressure, sensing ciliary musclecontraction for accommodation stimulus, dynamic pupil change, andretinal prostheses have been developed to assist in technology-assistedhealth care. Such body-mounted devices can be awkward to wear and someusers might prefer the positioning of the device in the body. Certainimplementations described herein can provide methods and devices forplacing a electronic device in the eye.

Certain implementations described herein relate to prosthetic capsulardevices (e.g., bags as defined in WO 2013/126380) that can be insertedinto an eye. A prosthetic capsular device may comprise an anteriorsurface including an opening, and a posterior surface. At least aportion of the posterior surface includes or is a refractive surface.The device includes a wearable electronic technology device (e.g., atechnology device). The prosthetic capsular device or a systemcomprising the prosthetic capsular device may include an intraocularlens or features similar to an IOL, such as may be used in cataractsurgery to replace the natural lens. The technology device and theintraocular lens may be positioned (e.g., in, around, etc. theprosthetic capsular device) such that the technology device does notinterfere with (e.g., block, distort) the sight lines through theintraocular lens.

A retinal prosthesis may be positioned in a prosthetic capsular device,and data collected by the prosthesis may be remotely transmitted to theoptic nerve, for example wirelessly. In some implementations in whichthe retinal prosthesis can function as the end receptor of light, theretinal prosthesis may interfere with (e.g., block, distort) the sightlines through the IOL.

A method for inserting a wearable technology device (e.g., a technologydevice) into an eye of a patient may comprise surgically removing a lensor cataract from a natural capsule, leaving the natural capsule in anempty state; inserting a prosthetic capsular device into the eye of thepatient (e.g., the prosthetic capsular device including an anteriorsurface having an opening, and a posterior surface, wherein at least aportion of the posterior surface includes or is a refractive surface);and inserting an electronic technology device into the prostheticcapsular device.

An intraocular lens may also be inserted into the prosthetic capsulardevice, and may be placed in the prosthetic capsular device such thatthe technology device does not interfere with (e.g., block, distort)sight lines through the intraocular lens, except optionally in the caseof a retinal prosthesis.

The methods summarized above and set forth in further detail below maydescribe certain actions taken by a practitioner; however, it should beunderstood that these steps can also include the instruction of thoseactions by another party. Thus, actions such as “inserting anintraocular lens into a prosthetic capsular device” include “instructingthe insertion of an intraocular lens into a prosthetic capsular device.”

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the devices and methods described herein willbe appreciated upon reference to the following description inconjunction with the accompanying drawings, wherein:

FIG. 1 depicts a cross-sectional side view of an eye including anexample of a prosthetic capsular device including an IOL;

FIG. 2 depicts a side view of the example prosthetic capsular deviceshown in FIG. 1;

FIG. 3 depicts an anterior plan view of the example prosthetic capsulardevice shown in FIG. 1;

FIG. 4A is a flow chart of an example method for inserting andpositioning a prosthetic capsular device into an eye;

FIGS. 4B-4G are photos of an example method for inserting andpositioning a prosthetic capsular device into an eye;

FIG. 4H is a side view of an example prosthetic capsular device;

FIG. 4I is an anterior view of the prosthetic capsular device of FIG.4H;

FIG. 4J is a cross-sectional view of the prosthetic capsular device ofFIG. 4H along the line 4J-4J of FIG. 4I;

FIG. 5 depicts a cross-sectional side view of an eye including anotherexample of a prosthetic capsular device containing including an IOL;

FIG. 6 depicts a side view of the example prosthetic capsular deviceshown in FIG. 5;

FIG. 7 depicts an anterior plan view of the example prosthetic capsulardevice shown in FIG. 5;

FIG. 8 depicts a side view of an example prosthetic capsular devicecomprising an outer surface including, around a perimeter of the outersurface, a continuous outer rim of tabs (e.g., comprising silicone) eachtab including an opening in a center of the tab, and the capsular deviceincluding an internal lip configured to hold haptics of an IOL;

FIG. 9A depicts a side view of another example prosthetic capsulardevice;

FIG. 9B depicts a side cross-sectional view of the prosthetic capsulardevice of FIG. 9A;

FIG. 9C depicts a posterior plan view of the prosthetic capsular deviceof FIG. 9A;

FIG. 9D depicts an anterior side perspective view of the prostheticcapsular device of FIG. 9A;

FIG. 10A depicts a side view of yet another example prosthetic capsulardevice;

FIG. 10B depicts a side cross-sectional view of the prosthetic capsulardevice of FIG. 10A;

FIG. 10C depicts a posterior plan view of the prosthetic capsular deviceof FIG. 10A;

FIG. 10D depicts an anterior side perspective view of the prostheticcapsular device of FIG. 10A;

FIG. 11A depicts a side view of still another example prostheticcapsular device;

FIG. 11B depicts a side cross-sectional view of the prosthetic capsulardevice of FIG. 11A;

FIG. 11C depicts a posterior plan view of the prosthetic capsular deviceof FIG. 11A;

FIG. 11D depicts a posterior plan view of still yet another exampleprosthetic capsular device;

FIG. 11E depicts an anterior side perspective view of the prostheticcapsular device of FIG. 11A;

FIG. 12A depicts a cross-sectional view of an eye including an exampleprosthetic capsular device containing including both a technology deviceand an IOL;

FIG. 12B depicts a front view of an example intraocular lens usable inthe example prosthetic capsular device shown in FIG. 12A in which thetechnology device surrounds the outer edge of the IOL (e.g., surroundsthe outer edge of the optical surface of the IOL);

FIG. 12C depicts a top front perspective of the example intraocular lensof FIG. 12B;

FIGS. 13A and 13B are photographs of animal study results annotated tohighlight certain features;

FIGS. 14A-14E are photographs of animal study results for a right eye ofa first rabbit;

FIGS. 15A-15E are photographs of animal study results for a left eye ofthe first rabbit;

FIGS. 16A-16E are photographs of animal study results for a right eye ofa second rabbit;

FIGS. 17A-17E are photographs of animal study results for a left eye ofthe second rabbit;

FIGS. 18A-18E are photographs of animal study results for a right eye ofa third rabbit;

FIGS. 19A-19E are photographs of animal study results for a left eye ofthe third rabbit;

FIGS. 20A-20E are photographs of animal study results for a right eye ofa fourth rabbit;

FIGS. 21A-21E are photographs of animal study results for a left eye ofthe fourth rabbit;

FIGS. 22A-22E are photographs of animal study results for a right eye ofa fifth rabbit;

FIGS. 23A-23E are photographs of animal study results for a left eye ofthe fifth rabbit;

FIG. 24A is a flowchart of an example of controlling focus of an IOLusing an external device;

FIG. 24B is a schematic of a system for controlling an electronic deviceusing an external device;

FIG. 24C is a flowchart of an example of controlling an electronicdevice using an external device;

FIG. 24D is a flowchart of another example of controlling an electronicdevice using an external device;

FIG. 24E is a flowchart of another example of controlling an electronicdevice using an external device;

FIG. 24F is a flowchart of another example of controlling an electronicdevice using an external device; and

FIG. 25 is a block diagram depicting an example computer hardware systemconfigured to execute software for implementing one or more embodimentsof electronic device control disclosed herein.

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

DETAILED DESCRIPTION

Some prosthetic capsular enclosure devices (e.g., prosthetic capsularbags) that can be used in the eye can hold at least one of a technologydevice (e.g., an electronic technology device (e.g., a wearableelectronic technology device (e.g., a miniaturized wearable electronictechnology device))) and an intraocular lens.

Examples of preferred prosthetic capsular devices that may be compatiblewith certain implementations described herein are disclosed in PCTPublished Patent Application No. WO 2013/126380, which is incorporatedherein by reference in its entirety. Some preferred prosthetic capsulardevices are described herein.

With reference to FIGS. 1-3, a prosthetic capsular device or PPL-C 10 isshown approximating the size, shape, and volume of a natural human lens.The dimensions of the prosthetic capsular device 10 may be variable, sothat physicians may order an implant that most closely matches the lensof the eye 12 being operated on. The human lens varies in thickness fromabout 3.5 millimeters (mm) to about 5.5 mm. A natural lens tends to bethicker in more hyperopic eyes and thinner in more myopic eyes. Anatural lens thickens over time, and increased age is associated with athicker lens on average. The diameter of the human lens is about 9 mm.In some implementations, the prosthetic capsular device 10 comprises asubstantially discoid (e.g., a substantially flat, substantiallycircular disc) and/or spheroid (e.g., prolate spheroid, oblate spheroid)shape having a thickness between about 1.5 mm and about 5.5 mm (e.g.,about 2.5 mm) and a diameter between about 8.5 mm and about 10 mm (e.g.,about 9 mm). For purposes of clarity, the thickness of the prostheticcapsular device 10 is the distance between the anterior surface 14 andposterior surface 16 of the prosthetic capsular device 10 along thevisual axis 15 (FIG. 2), for example in contrast with the thickness ofwalls of the device 10. The anterior surface 14 includes an arcuate(e.g., circular, oval) opening 18 having a diameter between about 5 mmand about 7 mm (e.g., about 6 mm), and has an exterior contour, such as,for example, a flange 20 (e.g., having a thickness between about 0.5 mmand about 1.5 mm (e.g., about 1 mm), substantially surrounding (e.g.,surrounding) and extending radially outwardly from the opening 18. Theflange 20 can assist in stabilization and/or centration of theprosthetic capsular device 10 by extending into and fitting in theciliary sulcus 22 (FIG. 1). The flange 20 may lack or be substantiallyfree of perforations, which may increase stability and appositionsurface area of the flange 20. The prosthetic capsular device 10 may bedimensioned to fit precisely in a capsulorhexis created by a femtosecondlaser.

At least a portion of the inner face or side 17 of the posterior surfaceor portion 16 of the prosthetic capsular device 10 may comprise arefractive surface, which may, for example, allow a pseudophakicrefraction to be performed intraoperatively with a known lens alreadyinside the eye 12, e.g., the posterior refractive surface 19. In theimplementation shown in FIGS. 1-3, substantially the entire inner face17 comprises a low power refractive surface (e.g., about +1 diopter(D)). While the posterior refractive surface 19 is generally discussedherein in terms of a +1 D surface, the posterior refractive surface 19may comprise any and all lens powers and designs that are currentlyknown in the art of intraocular lenses, including, but not limited to:spherical, aspheric, wavefront, convex, concave, multifocal(diffractive, refractive, zonal), toric, accommodative, ultraviolet (UV)filtering, and diffractive chromatic aberration reducing lenses, andoptical powers ranging from any positive diopter value (e.g., including+35 D and above) to any negative diopter value (e.g., including −35 Dand below).

The posterior refractive surface 19 may advantageously reduce therefractive power of the IOL to be placed in the device 10. For example,if the device did not include a posterior surface (e.g., comprised asimple or modified ring), then one or more IOL devices would provide allof the refractive power, which could increase the volume of the IOL,leading to a larger incision and associated complications. A posteriorrefractive surface implanted in the eye can advantageously allow for asecond refractive device to be coupled with (e.g., placed within, nextto, and/or on top of) the posterior refractive surface. The posteriorrefractive surface 19 can allow the ELP of the eye to be determinedalong with any residual refractive error. If any further refractiveerror is discovered, a second refractive device can be added to theposterior refractive surface 19 (e.g., immediately), which canneutralize the deficit and help ensure that the desired outcome isachieved. The posterior refractive surface 19 being integrally formedwith the remainder of the device 10, which can be accurately placed andanchored, can inhibit or prevent shifting of lateral and/orposterior-anterior position, rotation, tilt, etc. of the posteriorrefractive surface 19 that could lead to degradation of vision. Thecontinuous nature of the device 10 on all sides except for the anterioropening 18 can inhibit, reduce, or prevent ingrowth of lens epithelialcells, and thereby can inhibit or prevent formation of intra-lenticularopacifications.

The device 10 comprising a refractive surface 19, rather than being athrough hole of an annulus, for example, can reduce the volume of an IOLinserted therein, which may advantageously reduce incision size. Theposterior refractive surface 19 may provide protection for the naturalcapsular bag 24 during placement of an IOL. For example, the IOL isinhibited or prevented from directly contacting the natural capsular bag24 because the IOL instead contacts the device 10. For another example,vitreous is inhibited or prevented from contacting the IOL. Sidewalls ofthe device 10 that do not include apertures large enough for a portion(e.g., a haptic) of an IOL to prolapse through may provide protectionfor the natural capsular bag 24 during placement of an IOL, for examplebecause the IOL is inhibited or prevented from directly contacting thenatural capsular bag 24.

The prosthetic capsular device 10 is adapted to be implanted in the eye12. The prosthetic capsular device 10 preferably comprises abiologically-compatible material that would be inserted inside the eye12. The prosthetic capsular device 10 is preferably deformable so as tobe folded and inserted via an injection system through a cornealincision ranging between about 0.1 mm and about 10 mm, preferablybetween about 1.5 mm and about 3 mm. The size of the corneal incisionvaries based on several factors, including, for example, the volume ofthe prosthetic capsular device 10, the plasticity of the prostheticcapsular device 10, the volume of the injection cartridge through whichthe prosthetic capsular device 10 will be delivered, frictional forces,combinations thereof, and the like. The capsulorhexis is preferablybetween about 4 mm and about 7 mm (e.g., about 6 mm), although, if afemtosecond laser is used, the capsulorhexis should be less than thedilated diameter of the patient's pupil, as a femtosecond lasergenerally cannot create a capsulotomy through the iris. A capsulorhexiscreated manually may be about the same size as a capsulorhexis createdby a femtosecond laser, as direct visualization of the rhexis boundaryis advisable throughout the creation process. The capsulorhexis rangesbetween about 3 mm and about 8 mm, preferably between about 4 mm andabout 7 mm. During implantation, the folded prosthetic capsular device10 passes through the corneal incision, through the capsulorhexis, andinto the patient's natural capsular bag 24 (FIG. 1). The naturalcapsular bag 24 may be fully, partially, or not intact, or is missing ora remnant, although it is preferred to place the device 10 in an intactnatural capsular bag 24 other than the continuous curvilinearcapsulorhexis, devoid of natural lens material, with intact zonules. Ifthe natural capsular bag 24 is not sufficiently intact, alternativetechniques may be employed, for example to secure the device 10 to theposterior chamber (e.g., suturing the device 10 to the scleral wall).The prosthetic capsular device 10 preferably possesses sufficientelasticity to resume its pre-folded shape, for example byself-expanding, once positioned inside the eye 12. Intraocular lensescomprising materials including silicone, polyimide, collamer, andacrylic can have one or more of these capabilities. In someimplementations, the prosthetic capsular device 10 comprises abiologically-compatible, optically clear material similar or identicalto those used in foldable intraocular lenses.

The prosthetic capsular device 10 is preferably inserted in the naturalcapsular bag 24 of the eye 12 of a patient through the use of aninjection system. The injection system can allow the prosthetic capsulardevice 10 to be folded or automatically folded into a smaller shape asthe prosthetic capsular device 10 is advanced through the injectionsystem so as to allow the prosthetic capsular device 10 to fit throughan incision much smaller than the diameter of the unfolded prostheticcapsular device 10. Injection systems through which IOLs are injectedinto the eye, for example comprising a cylindrical cartridge and anadvancement rod on a screw type advancement system or plungeradvancement system, would be suitable for use with the prostheticcapsular device 10. Other injection systems are also possible.

The prosthetic capsular device 10 is preferably inserted in a naturalcapsular bag 24 of the eye 12 of a patient who has had cataract surgerywith the use of a laser (e.g., a femtosecond laser) to create acapsulorhexis, although insertion into natural capsular bag 24 aftermanual creation of the capsulorhexis is also possible. A femtosecondlaser may be used to create the capsulorhexis, for example after thesame femtosecond laser or a different femtosecond laser or a differentdevice was used to make the other incisions including the main wound,the paracentesis, and any corneal or limbal relaxing incisions. Thepatient's natural lens, for example clouded by a cataract such that itmay be itself termed a “cataract,” may be removed using techniques knownin the art. For example, the natural lens material may be broken up andvacuumed out, leaving the natural capsular bag 24 partially, fully, ornot intact, or being missing or a remnant. The residual cortex may beremoved using techniques known in the art such as viairrigation/aspiration. An aphakic refraction may be completed using anintraocular refracting device such as, for example, the ORA System,available from WaveTec of Aliso Viejo, Calif. An IOL calculation may beperformed using an algorithm such as, for example, the Mackoolalgorithm. The patient's natural capsular bag 24 and anterior segment 26may be inflated with a viscoelastic material, such as sodium hyaluronate(e.g., Provisc, Healon, Viscoat). The prosthetic capsular device 10 maybe loaded into an injection device, for example by being folded into asmall tubular shape, and injected into the natural capsular bag 24. Theviscoelastic material may be removed from behind the prosthetic capsulardevice 10 and from the anterior segment 26. A pseudophakic refractionmay be performed with a system similar to a standard auto-refractor orthe intraoperative WaveTec ORA System. This calculation is preferablyperformed using approved protocols. An intraoperative Optical CoherenceTomography system, such as the Zeiss OMPI Lumera 700 with ReScan 700,could be used to measure the exact position of the prosthetic capsulardevice 10 in the eye 12, relative to the cornea and the retina. Alongwith pre-operative measurements of the cornea and axial length, theposition of prosthetic capsular device 10 as determined by the OCTmeasurement could allow the surgeon to determine the power of a lensthat would provide the desired refraction using a vergence formula.

An example refraction using an approved protocol, and accompanyingbackground information, is discussed herein. Current state of the artrequires multiple independent variables to be measured so that thedependent variable of effective lens position can be estimated. Theseven independent variables in the Holladay 2 formula (one of the mostpopular modern formulas) are, in decreasing order of importance: (1)axial length, (2) average keratometric power, (3) horizontal white towhite, (4) refraction, (5) anterior segment depth, (6) lens thickness,and (7) age. These variables are then used to estimate the EffectiveLens Position. However, this position is simply an estimation orprediction. If the estimation or prediction of the position isincorrect, the post-operative refractive outcome will be compromised.Therefore, emphasis should be placed on the ability to determine the ELPrather than estimating the ELP. The prosthetic capsular device 10 canhelp determine the ELP in one, two, or more different ways, as describedherein.

FIG. 4A is a flow chart of an example method for inserting andpositioning a prosthetic capsular device 10 into a patient's eye 12,with continued reference to FIGS. 1-3. First, the lens thickness of apatient's natural lens is determined pre-operatively using knowntechniques. Next, a prosthetic capsular device 10 having a thicknesssimilar to the thickness of the patient's natural lens is selected.Selection of a prosthetic capsular device 10 sized such that the innerface 17 of the prosthetic capsular device 10 is at the same location asthe posterior surface of the patient's natural lens is preferred suchthat, when an IOL 28 is inserted in the prosthetic capsular device 10,that IOL 28 will be positioned in substantially the identical locationpreviously occupied by the patient's natural lens. Although the naturalcapsular bag 24 remains open, a combination of very thin lenses may beused such that lenses may be positioned slightly differently than thenatural lens as measured from cornea to lens surface or back surface toretina. The prosthetic lens of ideal power can be appropriatelyidentified and inserted in the eye 12 to provide the desired refractiveendpoint.

A femtosecond laser and/or manual keratome may be used to form the mainwound, the paracentesis, any corneal or limbal relaxing incisions. Thefemtosecond laser and/or manual technique may be used to create thecapsulorhexis. The patient's natural lens or cataract is then removedusing techniques known in the art. The residual cortex is removed usingtechniques known in the art, such as via irrigation/aspiration. Then,the patient's natural capsular bag 24 and anterior segment 26 are filledwith viscoelastic material, and the prosthetic capsular device 10 isinserted into the natural capsular bag 24. The viscoelastic material isthen removed from behind the prosthetic capsular device 10 and from theanterior segment 26 in preparation for performing a pseudophakicrefraction.

By being able to identify and control the position of the IOL 28,choosing an IOL 28 may be independent of the seven variables used forELP in the Holladay 2 formula. Rather, via theoretical vergenceformulas, the exact IOL 28 that can provide a desired refractive outcomecan be specifically calculated using keratometric power, effective lensposition, and axial length. The weakness of the formulas currently usedis the inability to accurately estimate or predict ELP. To confirm thatthe pre-operative theoretical calculation is correct, a refraction maybe performed in the operating room once the prosthetic capsular device10 is implanted in the patient's eye via a WaveTec ORA System,retinoscopy, or by other known methods. The refraction will technicallybe a pseudophakic refraction, as the posterior refractive surface 19 ofthe prosthetic capsular device 10 has a refractive power, such as, forexample, +1 diopter.

A method to determine the correct intraocular power for a piggyback lensmay be calculated by first determining the power of the IOL 28 to beimplanted using Equation 1:

$\begin{matrix}{{IOLe} = {\frac{1336}{\frac{1336}{\frac{1000}{\frac{1000}{PreRx} - V} + {Ko}} - {ELPo}} - \frac{1336}{\frac{1336}{\frac{1000}{\frac{1000}{DPostRx} - V} + {Ko}} - {ELPo}}}} & ( {{Eq}.\mspace{14mu} 1} )\end{matrix}$wherein: IOLe=IOL power; ELPo=effective lens position; Ko=net cornealpower; V=vertex distance; PreRx=pre-op refraction (also can representthe intra-operative refraction after the prosthetic capsular device hasbeen placed); and DPostRx=desired post-operative refraction.

The Effective Lens Position (ELP or ELPo) is the distance from thesecondary principal plane of the cornea to the principal plane of thethin-IOL equivalent. The keratometric power of the cornea (Kk) can beconverted to the net optical power of the cornea (Ko) using Equation 2:Ko=Kk*0.98765431  (Eq. 2)For example, if the Kk is 44.50 D, Ko=44.50 D*0.98765431=43.95 D. Thenet optical power of the cornea would then be 43.95 D.

By comparing the pre-operative theoretical IOL calculations with theaphakic refraction, the prosthetic capsular device refraction, and thepost-IOL implantation refraction, surgeons can greatly improve theaccuracy of their post-operative refractive outcomes.

Still referring to FIG. 4A, once the appropriate IOL 28 is selected, theprosthetic capsular device 10 and anterior segment 26 are refilled withviscoelastic material and, based on the residual refractive error, theappropriate IOL 28 is selected and inserted into the prosthetic capsulardevice 10. The viscoelastic material is then removed from the eye 12,and the wounds are closed through standard methods such as hydration,suturing, etc. A final confirmatory refraction may be completed whileensuring normal intraocular pressure, which can affect the position ofthe prosthetic capsular device 10 and IOL 28 inside the eye 12. Ifsignificant error was found at this point, the surgeon may remove theimplanted IOL and replace the implanted IOL with a more desirable IOL(e.g., having a more desirable refractive power), substantially withoutrisking damage to the fragile natural capsular bag 24, due to theprotective nature of having the IOL 28 contained in the prostheticcapsular device 10. The ability provided by the natural capsular device10 to remove and insert IOLs is described further herein.

The device 10 may be used as a stand-alone intraocular lens for theprimary correction of aphakia. A device 10 including a particular lensmay be chosen based on pre-operative measurements and/or theoreticalformulae. Intraoperative aberommetry could also be used in the aphakicmode to help aid in the selection of the device 10 including its lens orposterior refractive surface 19. While this technique and implementationdoes not necessarily take advantage of the improvement of ELP predictionand identification, use the device 10 as a stand alone intraocular lens,with the ability to contain other technology of various types forimplantation in the future, is a reasonable solution.

The following method or surgical procedure for implanting a prostheticcapsular device as described herein has been successfully used in animalstudies using three New Zealand white rabbits of same sex and weighingbetween 2.4 kg and 3.2 kg and in animal studies using five New Zealandwhite rabbits of same sex and weighing between 3.2 kg and 3.6 kg. Theanimals were quarantined for at least seven days and grossly checked forthe presence of any anomalies prior to the beginning of the procedure.Each animal was prepared for surgery by pupil dilation with 1%cyclopentolate hydrochloride and 2.5% phenylephrine drops, appliedtopically three times each spaced by a duration of five minutes.Anesthesia was obtained with an intramuscular injection of ketaminehydrochloride (50 mg/kg) and xylazine (7 mg/Kg) in a mixture of 7:1,respectively. One drop of topical proparacaine hydrochloride anestheticwas also placed in each eye prior to beginning surgery. Eye movement andanimal respiration were monitored intraoperatively to ensure thatadequate levels of anesthesia were maintained. Supplemental anestheticswere given intramuscularly as needed during the operation. The areaaround the eye was draped in an aseptic manner. A lid speculum wasplaced to retract the lids. One drop of povidone-iodine (PVP-I) 5% and adrop of antibiotic was placed on the surface of the eye just beforebeginning surgery. Using aseptic technique and a Zeiss surgicalmicroscope, a fornix-based conjunctival flap was fashioned. Acorneal-scleral incision was made using a crescent blade, and an initial3.0 mm limbal incision was made using a 3.0 mm keratome to enter theanterior chamber. Capsulorhexis forceps were used to create a wellcentered continuous curvilinear capsulotomy (CCC), with a diameterbetween about 5.0 mm and about 5.5 mm.

After hydrodissection, a phacoemulsification handpiece (Alcon Infinitisystem) was inserted into the posterior chamber for removal of lensnucleus and cortical material. One milliliter (mL) of epinephrine 1:1000and 0.5 mL of heparin (10,000 USP units/mL) were added to each 500 mL ofirrigation solution to facilitate pupil dilation and controlinflammation. The endocapsular technique was used with thephacoemulsification to take place entirely within the natural capsularbag. The residual cortex was then removed with the anirrigation/aspiration (I/A) handpiece. After removal of the naturallens, an ophthalmic viscosurgical device (OVD) (Amvisc Plus, Bausch &Lomb) was used to inflate the natural capsular bag.

As shown in FIGS. 4B-4D, the prosthetic capsular bag was then injectedby using an appropriate injector system (“A” cartridge and Monarch IIinjector from Alcon Laboratories; Accuject 2.2-1P injector set fromMedicel), after the surgeon slightly increased the incision size.Loading of the prosthetic capsular device into the injectors was foundto be uneventful. If the prosthetic capsular device was injectedpartially out of the natural capsular bag (e.g., due to fibrinformation, papillary restriction, injector limitation, etc.), theprosthetic capsular device was able to be manipulated with a collarbutton hook to complete in-the-bag fixation. Careful control of theinjector may inhibit or prevent rapid or uncontrolled release of theprosthetic capsular device from the injector. Even when the plunger ofan injector overrode the prosthetic capsular device inside the plunger,injection in the natural capsular bag was possible.

As shown in FIGS. 4E-4G, this was followed by insertion of IOLs (AcrySofSN60AT, a single-piece hydrophobic acrylic IOL manufactured by Alcon)using the Monarch II injector and “C” cartridges. The AcrySof lens wasfully fixated within the prosthetic capsular device in all instances,uneventfully. The device and IOL were carefully inspected under highmagnification for any possible damage that might have occurred duringthe loading/implantation process. Centration of the prosthetic capsulardevice and of the IOL inside of the prosthetic capsular device was foundto be excellent in all cases. In three eyes, the natural capsular bagcontaining the prosthetic capsular device and the AcrySof lens wasslightly oval.

Combination antibiotics/steroid ointment (neomycin and polymyxin Bsulfates, and dexamethasone) was applied to the eyes following surgery.The same ointment was placed in the eyes four times per day for thefirst postoperative week. Ointment was discontinued after one week. Inthe second postoperative week, each animal received topical prednisoloneacetate drops four times per day. In the third postoperative week, eachanimal received topical prednisolone acetate drops two times per day,with discontinuation of the drops following the third postoperativeweek.

The eyes were evaluated grossly at day one, and by slit lamp examinationwith scoring for ocular inflammatory response at one, two, three, andfour weeks postoperatively (±2 days) and photographs were taken (seebelow). At each of these examinations, the rabbit eyes were dilatedusing a combination of cyclopentolate hydrochloride solution andphenylephrine. A standard scoring method in eleven specific categorieswas used at each examination, including assessment of corneal edema, aswell as the presence of cell and flare within the anterior chamber.Retro-illumination images with the pupil fully dilated were obtained forthe purpose of photographic documentation regarding CCC size, anteriorcapsule opacification (ACO), posterior capsule opacification (PCO), andany observed capsular fibrosis at the discretion of the study directors.The images are provided and discussed in further detail herein.

After the clinical examination at four weeks, the animals wereanesthetized using a 1 to 2 cm³ (cc) intramuscular injection of a 7:1mixture of ketamine hydrochloride and xylazine, and then humanelyeuthanized with a 1 mL intravenous injection of pentobarbitalsodium/phenytoin sodium. The globes were enucleated and placed in 10%neutral buffered formalin. The globes were then bisected coronally justanterior to the equator. Gross examination and photographs from theposterior aspect (Miyake-Apple view) were performed to assess the ACOand PCO development, as well as IOL fixation. The extent and severity ofACO and PCO were scored according to established methods.

After gross examination and photographs, all globes were sectioned andthe anterior segments including the capsular bags were processed forstandard light microscopy and stained with hematoxylin and eosin (H &E). Features such as cell type, extent and route of growth, etc. weredocumented by serial photomicrographs.

FIGS. 4H-4J illustrate another example prosthetic capsular device 400,in which FIG. 4H is a side view, FIG. 4I is an anterior plan view, andFIG. 4J is a cross-sectional view of along the line 4J-4J of FIG. 4I.The device 400 is illustrative of the prosthetic capsular devices usedin the animal studies described herein, with certain modifications whereindicated.

The device 400 comprises a posterior side 402 and an anterior side 404.The posterior side 402 has a diameter 408 between about 5 mm and about10 mm (e.g., about 9.5 mm). The anterior side 404 has a diameter 410between about 5 mm and about 10 mm (e.g., about 9 mm). The diameter 410of the anterior side 404 may be between about 0.25 mm and about 1 mm(e.g., about 0.5 mm) less than the diameter 408 of the posterior side.The device 400 comprises a generally cylindrical portion having thediameter 408 from the posterior side 402 to the flange 406, a taperedportion tapering from the diameter 408 to the diameter 410 anterior tothe flange 406, and another generally cylindrical portion having thediameter 410 from the tapered portion to the anterior side 404. Thetapered portion may be straight, arcuate, and/or combinations thereof.

The posterior side 402 has a generally flat end shape and a roundedrefractive portion 414 inwardly set back from the end of the posteriorside 402, as best seen in FIG. 4J. The refractive portion 414 provides arefractive property to the device 400. The refractive portion 414 has adiameter 424 between about 4 mm and about 9 mm (e.g., about 5.9 mm). Theillustrated refractive portion 414 has a refractive power of 5 D with aradius of curvature 426 of about 19.32 mm) although other refractivepowers (e.g., 0 D, <0 D, >0 D, ±35 D, etc.) and radii of curvature(e.g., at least partially depending on one or more of refractive power,the diameter 424, material, etc.) are also possible.

The anterior side 404 comprises an opening 410, which allows theinsertion of an IOL as discussed herein. The opening 410 may have adiameter 418 between about 5 mm and about 10 mm (e.g., about 9 mm). Thesidewalls of the device 400 optionally do not extend radially inwardlysuch that the opening 410 may have a large or maximum diameter (e.g.,based on the diameter of the inner surface of the sidewalls of thedevice 400). A larger opening 410 may aid insertion of the IOL and/orreduce volume and/or mass, which can aid insertion into small incisions(e.g., by being easier to compress into and/or advance through aninjection device). A smaller opening 410 may aid in containment of anIOL (e.g., better defining the interior volume of the device 400 and/orinhibiting anterior drift on an inserted IOL). The anterior side 404and/or the posterior side 402 may comprise a lip or ridge 432 on aradial exterior.

The distance 430 between the flange 406 and the refractive portion 414may be between about 0.5 mm and about 2 mm (e.g., about 1 mm). Thedistance 420 between the anterior end 404 and the refractive portion 414may be between about 1 mm and about 5 mm (e.g., about 2.5 mm). Asdescribed herein, in devices comprising a flange, the flange may beanywhere along the longitudinal axis of the device.

The device 400 comprises sidewalls between the posterior end 402 and theanterior end 404. The sidewalls may have a radial thickness 422 betweenabout 0.1 mm and about 0.5 mm (e.g., about 0.26 mm). The sidewallsoptionally extend posterior to the refractive portion 414 and/oranterior to or substantially longitudinally even with the opening 412.The sidewalls may extend towards the anterior side 404 and/or theposterior side 402 to form a lip or ridge 432.

The device 400 illustrated in FIGS. 4H-4J includes a flange or ring 406having an anterior-posterior thickness 428 of about 0.3 mm and a radialthickness ((diameter 416−diameter 408)/2) of about 0.25 mm, but theflange 406 was removed from the devices used in the animal studies suchthat the outer diameter of the devices was the diameter 408. If theflange 406 is not removed, other thicknesses are also possible. Forexample, a flange 406 having thicker dimensions may be less prone totearing upon loading in a delivery syringe and/or insertion in an eye.

The prosthetic capsular device 10 can enhance the ability to achievedesired refractive targets, with a side benefit of increased safety. Theprosthetic capsular devices (e.g., the prosthetic capsular device 10and/or variants thereof) described herein can provide one or more ofthese advantages in one or more of several ways. Although variousnumbered potential advantages are listed, each advantage may includesub-advantages or alternative advantages, and not all devices 10 need toaccomplish every enumerator or otherwise described potential advantage.

First, with reference again the FIGS. 1-3, the prosthetic capsulardevice 10 can provide centration of the IOL 28 along the visual axis 15.A femtosecond cataract laser system has the ability to center thecapsulorhexis around the visual axis 15 of the patient rather than theoptical center of the cataract. The capsulorhexis is ultimately whatwill center the prosthetic capsular device 10 as the capsulorhexis isthe opening through which the prosthetic capsular device 10 will beinserted. The capsulorhexis is juxtaposed at the center of theprosthetic capsular device 10, centering the prosthetic capsular device10. The prosthetic capsular device 10 may optionally be stabilized viathe flange 20 extending into and fitting in the ciliary sulcus 22. Theflange 20 can mechanically retain the prosthetic capsular device 10centered on the patient's visual axis 15 and inhibit or prevent futuremovement or migration of the prosthetic capsular device 10, althoughcentering and inhibited movement are also possible without a flange 20.

Centration of the IOL 28 on the visual axis 15 can be important to thevisual function of the IOL 28 and the benefit the patient receives.Aspheric lenses have made decentration more tolerable, however improvedcentration can be advantageous to the increase or optimize visualperformance of multifocal intraocular lenses. Decentration by less than1 mm can cause significant morbidity, so much so that surgicalintervention including laser pupiloplasty, IOL repositioning, and IOLexchange are often performed. The prosthetic capsular device 10 iscentered along the visual axis 15 via the capsulorhexis. An IOL 28commonly includes haptics 30 which can engage opposed interior surfacesin the prosthetic capsular device 10 to maintain the centered positionof the IOL 28. The outer diameter of the IOL 28, when unfolded andincluding the haptics 30, may be substantially equal to or less than theinner diameter of the prosthetic capsular device 10. The IOL 28 can becentered by being in physical contact with the peripheral internalsurface of the prosthetic capsular device 10 that is centered in thevisual axis 15, which maintains the centered position of the IOL 28 inthe prosthetic capsular device 10 and also in the visual axis 15.

Second, the prosthetic capsular device 10 can provide a prostheticbarrier between the anterior segment 26 and posterior segment 32 of theeye 12 in the case of inadvertent rupture of the posterior surface ofthe natural capsular bag 24, or after planned neodymium-doped yttriumaluminum garnet (Nd:YAG) laser posterior capsulotomy. Despite theoverall success of cataract surgery, there is still about 2% surgicalcomplication rate utilizing modern techniques, although this variesamong individual surgeons. Residents in ophthalmology training programshave historically had complication rates around 4-7%. Most complicationsfrom cataract surgery are caused by inadvertent rupture of the naturalcapsular bag 24, which houses the cataract. The natural capsular bag 24also provides an important anatomical barrier within the eye 12 bydividing the anterior segment 26 from the posterior segment 32. Theposterior segment 32 contains the vitreous body, retina, optic nerve,and the central retinal artery and vein. A violation of the integrity ofthe barrier provided by the natural capsular bag 24 allows fluidcommunication between the anterior segment 26 and the posterior segments32, and potentially the ocular surface. Vitreous may flow out of theposterior segment 32 according to pressure gradients, flowing from highpressure (e.g., in the posterior segment 32) toward low pressure (e.g.,the anterior segment 26). A pressure gradient can cause vitreous to flowdirectly to the surgical incision site in the lower pressure anteriorsegment 26. Vitreous can inhibit or prevent wound healing if present atthe surgical incision site, and more significantly can provide a conduitfor microbial infections to proceed directly to the posterior segment32. In addition to the problems caused by vitreous, a break or tear inthe natural capsular bag 24 can inhibit or prevent the stableimplantation of an IOL 28 in the posterior segment 32. Surgeons canplace an IOL 28 in the ciliary sulcus 22 or the anterior chamber,although each of these alternatives has their own potentialcomplications associated with them. The natural capsular bag 24 isdesirably maintained intact, as there are currently no methods toconsistently reestablish the integrity of the natural capsular bag 24once it has been compromised. Should the natural capsular bag 24 becompromised, the prosthetic capsular device 10 may serve as a prostheticbarrier between the anterior segment 26 and posterior segment 32.

About 30% of all implanted intraocular lenses develop visuallysignificant posterior capsular opacification. If this develops, a Nd:YAGlaser may be used to create an opening in the posterior surface of thenatural capsular bag 24 to remove this opaque membrane. If the IOL 28 isto be removed after a Nd:YAG laser posterior capsulotomy has beenperformed, the chances for serious complications rise dramaticallybecause the barrier between the vitreous and the anterior segment 26 hasbeen lost due to the Nd:YAG-created opening in the posterior surface ofthe natural capsular bag 24. If a prosthetic capsular device 10 isplaced in the natural capsular bag 24 and Nd:YAG laser posteriorcapsulotomy has been performed, the prosthetic capsular device 10 canprovide an adequate barrier for the vitreous, inhibiting or preventingvitreous from flowing out of the posterior segment 32. The haptics 30,which hold the IOL 28 in place inside the prosthetic capsular device 10,are not prone to scar formation or fibrosis because they contact theprosthetic capsular device 10 rather than the natural capsular bag 24,which can make future lens removal easier and decrease the risk forcomplications during IOL 28 exchange. The prosthetic capsular device 10can provide a platform for routine IOL 28 exchange, as described furtherherein.

Third, the prosthetic capsular device 10 can limit chronic capsularopacification that takes place in the natural capsular bag 24 and thatcan cause refractive shifts due to ELP change, anterior capsularphimosis, and visually significant posterior capsular opacification.After cataract surgery has been performed, the natural capsular bag 24undergoes chronic changes. These changes are largely due to the presenceof lens epithelial cells that remain on the natural capsular bag 24after surgery. These epithelial cells continue to grow and can causeproblems. For example, the anterior surface of the natural capsular bag24 can fibrose and contract over time, causing a progressively smalleraperture overtop of the lens. If the entire natural capsular bag 24becomes fibrotic, and phimosis persists, there can be zonular dehiscenceand changes to the effective lens position over time. About 30% of thetime, the posterior surface of the natural capsular bag 24 becomessignificantly opacified, which may be remedied by a Nd:YAG laserposterior capsulotomy. The effect of limiting epithelial cell migrationand propagation can be mediated by the type of material that theprosthetic capsular device 10 comprises (e.g., hydrophobic acrylicmaterials, which tend to be most efficacious of all currently known andused IOL materials).

Fourth, the prosthetic capsular device 10 can help maintain theeffective lens position of an IOL 28 implanted into the eye 12.Precisely matching the preoperative dimensions of the cataract with theprosthetic capsular device 10 can enhance the ability to predict the ELPof the lens implant 28. Currently, the ELP of an IOL 28 is estimated orpredicted based on a number of factors, including the depth of theanterior segment 26, lens thickness, and white to white diameter, amongothers. The accuracy of the prediction is actually quite low, resultingin only 50% of patients being within a tolerable level of theirrefractive goal post-cataract surgery. While other dimensions of the eyerequired for standard IOL calculation can be measured quite preciselyand accurately, the ELP has remained the elusive last great variable toconquer in the quest for highly accurate and predictable IOLcalculations for cataract surgery.

The reason for the great variability in the ELP is due to the volumetricdifference between the cataract and the IOL 28. The average thickness ofthe human cataract at age 65 is approximately 4.5 mm, but varies frompatient to patient. In contrast, an IOL 28 is typically less than 1 mmthick. The thickness of the IOL generally does not match the thicknessof the cataract due to deliverability issues, as thicker IOLs generallyuse a larger incision. The resulting volumetric difference allows forpressure differentials between the posterior segment 32 and the anteriorsegment 26, as well as contraction of the natural capsular bag 24, whichcan shift the final resting position of the IOL 28. The lens thicknessmay be measured preoperatively and a prosthetic capsular device 10 witha corresponding volume and thickness may be implanted. By implanting aprosthetic capsular device 10, the volume of the natural capsular bag 24may effectively be held constant and/or in accordance with the cataract.The natural capsular bag 24, buttressed by the prosthetic capsulardevice 10, can resist forces that would otherwise shift the naturalcapsular bag 24 and its contents anteriorly or posteriorly. Thisstability of lens capsule volume can increase or significantly increasethe accuracy of IOL calculations.

Fifth, the prosthetic capsular device 10 can allow for an intraoperativepseudophakic refraction while still allowing another IOL to be implantedwithout explanting an originally implanted lens. Recently, there havebeen advances in IOL calculation methodologies that use intraoperativerefraction devices, such as the WaveTec ORA System, the WaveTec OrangeSystem, the HOLOS IntraOp from Clarity Medical Systems, Inc., etc., toprovide better refractive outcomes. These devices can perform aphakicrefractions, pseudophakic refractions, and assist with the alignment oftoric IOLs 28 and assist with Limbal Relaxing Incisions. Aphakicrefractions do not have the benefit of a lens inside the eye, so ELP isstill a variable for which this data cannot account. Pseudophakicrefractions can be helpful, but provide the information only after theIOL 28 has been implanted. If the data shows that a different IOL 28would be more beneficial, the physician would explant the lessbeneficial IOL 28 and implant a more beneficial IOL 28. Explanting anIOL 28 takes time, effort, and skill, and can cause damage to thenatural capsular bag 24, zonules, cornea, and/or other structures withinthe eye 12. Using a prosthetic capsular device 10 with a low power lensincorporated into its posterior surface (e.g., the posterior refractivesurface 19) can allow a physician to perform a pseudophakic refractionwith this refractive surface, and still provides the physician theability to implant a second lens (e.g., the IOL 28) within theprosthetic capsular device 10 that will make up the refractivedifference as measured by an intraoperative refraction device, such asthe WaveTec ORA System and Clarity HOLOS.

Stabilization of the natural capsular bag 24 by insertion of theprosthetic capsular device 10 can be leveraged to perform anintraoperative optical coherence tomography (OCT) measurement and/or Aor B scan ultrasound, for example using commercially available systemssuch as the Zeiss RESIGHT OCT and/or any of a multitude of ophthalmicA/B scan ultrasound systems. Once the prosthetic capsular device 10 isinserted into the natural capsular bag 24, the anterior and posteriorcapsule can be stented open into a stable configuration, which should beunlikely to significantly change post operatively. By knowing thecorneal power, the distance from the cornea to the refractive surface ofthe prosthetic capsular device 10, and the distance from the refractivesurface of the prosthetic capsular device 10 to the surface of theretina, the ELP can be determined. By knowing the ELP, the power of thecornea, the refractive power built in to the posterior aspect of theprosthetic capsular device 10, and the axial length of the eye 12 (e.g.,from the surface of the corneal epithelium to the internal limitingmembrane (ILM) (ultrasonic technique), the retinal pigment epithelial(RPE) layer (laser interferometry technique), from cornea to retina), anappropriate second lens (e.g., of an IOL) can be selected and implantedinto the open space in the prosthetic capsular device 10 to provide thedesired refractive outcome.

Sixth, the prosthetic capsular device 10 may serve as a means forpharmaceutical delivery. Pharmaceuticals, drugs, and medications, suchas, for example, slow release fully or partially dissolvable medicinepellets, non-dissolvable prostheses coated with slow releasepharmaceutical agents, and/or other substances intended for introductioninto the eye 12 may be placed in and/or on prosthetic capsular device 10outside of the visual axis 15 in a location that is not subject tosequestration by membrane formation. There is a tremendous amount ofresearch and demand for a slow release implant that would essentiallyeliminate the need for post-cataract surgery eye drops. The prostheticcapsular device 10 would be a suitable receptacle for such an implant,as the periphery of the interior of the prosthetic capsular device 10provides a location outside of the visual axis 15, in constant contactwith the aqueous humor, substantially without risk of becomingencapsulated by scarring. Due to the prosthetic material of theprosthetic capsular device 10, there would be little to no risk ofmembrane formation or encapsulation. Dissolved or suspendedpharmaceuticals would not affect the patient's vision and could beintroduced directly into the prosthetic capsular device 10 during theimplantation surgery. Larger pharmaceuticals, such as slow releasemedicine pellets, may be shaped to mechanically maintain their positionwith respect to the prosthetic capsular device 10. For example, a slowrelease medicine pellet may be constructed with a generally toroidalshape sized to fit within the prosthetic capsular device 10, whileremaining in the peripheral space and not obstructing the visual axis15.

Seventh, the prosthetic capsular device 10 may provide physicians withthe ability to perform a lens exchange in the future that can reduce orminimize the risk of damage to the natural capsular bag 24 and zonularapparatus, which ultimately can substantially reduce or minimize therisk of serious vision threatening sequlae such as macular edema,macular hole, retinal tear, retinal detachment, proliferativevitreoretinopathy, and/or loss of capsular support leading to lessfavorable lens implantation techniques (e.g., a sutured or glued IOL 28,an anterior chamber IOL 28, a posterior chamber IOL 28, etc.). As statedabove, if a prosthetic capsular device 10 is placed in the naturalcapsular bag 24 and a Nd:YAG laser posterior capsulotomy has beenperformed, the prosthetic capsular device 10 provides an adequatebarrier for the vitreous. The haptics 30 which hold the IOL 28 in placeinside the prosthetic capsular device 10 are not prone to scarformation, making future removal and/or exchange of the IOL 28 easier.

FIGS. 5-7 depict another example prosthetic capsular device 110. Theprosthetic capsular device 110 is a substantially discoid shape having athickness between about 2.5 mm and about 4.5 mm and a diameter of about9 mm, although other dimensions, for example as described herein withrespect to the prosthetic capsular device 10, 400, are also possible.The thickness of the prosthetic capsular device 110 is the distancebetween the anterior surface 114 and posterior surface 116 of theprosthetic capsular device 110 along the visual axis 15. The anteriorsurface 114 contains a circular opening 118 having a diameter of about 6mm. At least a portion of the inner face 117 of the posterior surface116 of the prosthetic capsular device 110 comprises a refractivesurface, e.g., the posterior refractive surface 119. The prostheticcapsular device 110 lacks or is free of a flange 20 (as in theprosthetic capsular device 10) that could mechanically fixate or centerthe prosthetic capsular device 110 on the capsulorhexis. The volume ofthe prosthetic capsular device 110 relative to the opening of thecapsulorhexis may keep the device in place similar to the manner inwhich current single piece IOLs 28 are folded and placed within thenatural capsular bag 24.

The prosthetic capsular device 110 may sacrifice a measure of stabilityas compared to the prosthetic capsular device 10 comprising a flange 20.Without a flange, the prosthetic capsular device 110 may be usable fornon-femtosecond laser cataract removal (e.g., traditional manualphacoemulsification), and may be particularly useful for surgeons wholack access to a femtosecond laser.

The lenticular surface on the posterior aspect of a prosthetic capsulardevice may have a plano powered lens. Some extreme myopes would notbenefit from a +1 D refractive surface, as they may benefit from anegative IOL 28 power. For patients with these conditions, a prostheticcapsular device may be used with a plano or zero power posteriorlenticular surface.

The prosthetic capsular device may have a posterior refractivelenticular surface (e.g., −1 D), as some extreme axial myopes (about 30mm and beyond) may benefit from this type of lens.

The posterior refractive surface of a prosthetic capsular device maycomprise a multifocal lenticular surface, which could aid in presbyopiacorrection. This multifocal lenticular surface may include, but is notlimited to, refractive, diffractive, and zonal multifocal refractivetechnology. A multifocal lens may be designed to provide multiple focalpoints generally ranging from plano (e.g., 0 D) to +3 D or greater atthe spectacle plane.

The posterior refractive surface of a prosthetic capsular device mayinclude a spherical, aspheric, and/or cylindrical (astigmatic)lenticular surface so as to aid in the correction of pre-existing andsurgically induced corneal astigmatism. As most surgeons induce between−0.25 D and −0.50 D of astigmatism with their corneal incisions requiredfor cataract surgery, it would be beneficial even for most patients withspherical corneas to have this neutralized. The diopteric power of thetoric correction could increase up to 6 diopters for patients with evenhigher amounts of astigmatism.

In some implementations described herein (e.g., the prosthetic capsulardevice 110 shown in FIG. 6, the prosthetic capsular device 400 with theflange 406 removed or never formed), the prosthetic capsular device(e.g., bag, bowl, housing, structure, cage, frame) does not include oris free of a flange. Certain such implementations may include, around aperimeter of the prosthetic capsular device 210, an outer rim comprisingtabs or haptics 205. The rim may be continuous, and tabs 205 that are incontact may be considered continuous. Tabs 205 that are continuous mayprovide better apposition with the natural capsular bag and/or be moreform fitting than a device in which the tabs 205 are not continuous. Thetabs 205 may position (e.g., center) the device 210 in a desiredposition. Some or all of the tabs 205 may include an opening or hole220, for example in the approximate center of the tab 205. An exampleprosthetic capsular device 210 comprising a continuous outer rimcomprising tabs 205 each including an opening or hole 220 is illustratedin FIG. 8. The rim, tabs 205, and/or openings 220 can assist theprosthetic capsular device 210 to fit inside natural capsular bags ofmany sizes and shapes. The prosthetic capsular device 210 preferablyallows for some fibrosis through the openings 220, which can stabilizethe capsule 210 in the event of a Nd:YAG laser posterior capsulotomy.The tabs 205 can comprise, for example, silicone, silicone derivatives,acrylic, acrylic derivatives, biocompatible methacrylates (e.g.,poly(methyl methacrylate) (PMMA)), collamer, olefins (e.g.,polypropylene), polyimide, combinations thereof, and the like. The tabs205 may comprise the same material as (e.g., be integrally formed with)the remainder of the device 210 or may comprise a different materialthan the remainder of the device 210 (e.g., being overmolded over theremainder of the device 210). The device 210, like other prostheticcapsular bags described herein, may comprise a plurality of piecesand/or materials, which may advantageously allow selection or use of amaterial suitable for the function of that component, as opposed toselection or use of a material having compromising suitability forseveral functions. If the remainder of the device 210 comprises opaquematerial, the tabs 205 may comprise opaque and/or transparent material,for example because the opaque material of the remainder of the device210 can reduce or minimize intraocular scattering and/or glare such thatlight may not reach the tabs 205. The prosthetic capsular device 210 caninclude an internal lip 230. The internal lip 230 can run partially,intermittently, or completely around the inside of the prostheticcapsular device 210. The lip 230 may be designed to hold the haptics ofan IOL stable, inhibiting or preventing the lens from rotating orshimmering during eye movements.

In some implementations, the prosthetic capsular device intentionallymoves away from natural form fitting conformation of the posterioraspect of the device. This can allow for the posterior aspect of theprosthetic capsular device to have a larger diameter (e.g., the largestdiameter possible for the physiology), potentially allowing for implantswith a wider diameter to be implanted, and to have a more stabilizingeffect on the lens that the device will be holding.

In some implementations, the prosthetic capsular device 210 comprises atleast one of the following: external form-fitting elements (e.g., thetabs 205 shown in FIG. 8); openings in the external form-fittingelements through which fibrosis can take place, thereby allowingstabilization of the positioning of the device (e.g., the openings 220in the tabs 205 shown in FIG. 8); and an internal lip/sulcus configuredto secure the haptics of a standard IOL (e.g., the lip 230 shown in FIG.8).

FIGS. 9A-9D illustrate another example prosthetic capsular device 900,in which FIG. 9A is a side view, FIG. 9B is a side cross-sectional view,FIG. 9C is a posterior plan view, and FIG. 9D is an anterior sideperspective view. The prosthetic capsular device (e.g., bag, bowl,housing, structure, cage, frame) 900 does not include or is free of aflange, although combination with a flange (e.g., the flange 20) is alsopossible. The device 900 comprises a posterior side 902 and an anteriorside 904. The posterior side 902 has a generally rounded shape. As shownin FIG. 9B, the posterior side 902 comprises a refractive portion, whichprovides a refractive property to the device 900.

As shown in FIGS. 9B and 9D, the anterior side 904 comprises an opening910, which allows the insertion of an IOL as discussed herein. Theopening 910 may have sharp edges (e.g., as depicted in FIGS. 9B and 9D),rounded edges (e.g., as shown in other implementations herein), etc. Theopening 910 may have a diameter between about 5 mm and about 10 mm(e.g., between about 6 mm and about 9 mm). The sidewalls of the device900 optionally do not extend radially inwardly such that the opening 910may have a large or maximum diameter (e.g., based on the diameter of theinner surface of the sidewalls of the device 900). A larger opening 910may aid insertion of the IOL and/or reduce volume and/or mass, which canaid insertion into small incisions (e.g., by being easier to compressinto and/or advance through an injection device). A smaller opening 910may aid in containment of an IOL (e.g., better defining the interiorvolume of the device 900 and/or inhibiting anterior drift on an insertedIOL).

As shown in FIGS. 9B and 9D, the device 900 comprises an internal lip912. The internal lip 912 can run partially, intermittently, orcompletely around the inside of the prosthetic capsular device 900. Thelip 912 may be designed to hold the haptics of an IOL stable, inhibitingor preventing the lens from rotating or shimmering during eye movements.The lip 912 is proximate to a midpoint of the device 900, for examplebeing proximate to a plane about half way between the posterior side 902and the anterior side 904. The lip 912 may be proximate to the anteriorside 902, proximate to the anterior side 904, etc., and can be designedand/or selected based on the IOL to be inserted into the device 900. Thedevice 900 may comprise a plurality of lips 912, for example configuredto engage a plurality of IOLs and/or to provide a plurality ofalternative positions to engage one IOL. The lip 912 may comprise atubular structure, for example configured to lockingly engage haptics ofan IOL (e.g., by insertion of end portions of one or more haptics into alumen of the tubular structure, by resilient compression of the tubularstructure by a haptic, etc.). Rather than extending radially inwardly(e.g., as shown in FIGS. 9B and 9D), the lip 912 could extend radiallyoutwardly, for example comprising a groove in the inner sidewalls of thedevice 900. A lip 912 comprising a groove may be integrally formed(e.g., during molding of the device 900) and/or formed after (e.g., bylaser milling). Combinations of the lips 912 described herein are alsopossible. For example, the lip 912 could comprise: one or a plurality oflips 912; position(s) proximate to a surface and/or a midpoint;continuous and/or intermittent; filled and/or tubular; a grooveextending into the sidewalls of the device 900; and combinationsthereof.

The device 900 comprises, around a perimeter of the device 900, aplurality of tabs or haptics 906. The tabs 906 are not in contact andmay be considered not continuous. Tabs 906 that are not continuous mayuse less material and impart less volume and/or mass to the device 900,allowing the device 900 to be easier to insert into small incisions. Useof less material may reduce costs due to use of less material. Asdiscussed above, tabs that are continuous may provide better appositionwith the natural capsular bag and/or be more form fitting, but may usemore material and impart more volume and/or mass to a device, which caninhibit insertion into small openings. Depending on the application, thedevices described herein that include tabs may include tabs that arecontinuous, not continuous, and combinations thereof (e.g., comprisingcontinuous tabs over a portion of the perimeter).

The tabs 906 comprise an opening or hole or aperture 908. The openings908 illustrated in FIGS. 9A-9D extend all of the way through the tabs906, but could extend only partially through the tabs 906. The openings908 may assist in suturing the device 908, allow fibrosis therethrough,etc. The tabs 906 include tabs 906 a that are anteriorly biased and tabs906 b that are posteriorly biased. Biased tabs 906 (e.g., tabs 906 a,906 b having alternating bias) can inhibit preferential torqueing andtilt. In addition and/or alternatively to being differently biased, thetabs 906 may have other differences (e.g., shape, material, absence ofan opening 908, anterior-posterior position, orientation, combinationsthereof, and the like).

FIGS. 10A-10D illustrate yet another example prosthetic capsular device1000, in which FIG. 10A is a side view, FIG. 10B is a sidecross-sectional view, FIG. 10C is a posterior plan view, and FIG. 10D isan anterior side perspective view. The prosthetic capsular device (e.g.,bag, bowl, housing, structure, cage, frame) 1000 does not include or isfree of a flange, although combination with a flange (e.g., the flange20) is also possible. The device 1000 comprises a posterior side 1002and an anterior side 1004. The posterior side 1002 has a generally flatshape. As shown in FIG. 10B, the posterior side 1002 comprises a solidsurface, but substantially constant thickness and parallel planarsurfaces are indicative of a lack of a refractive portion, which may beuseful if the IOL provides sufficient refractive power (e.g., if thediopter value is low). Although the posterior side 1002 is flat, theinterior surface of the posterior part of the device 1000 could becurved such that the device 1000 can provide refractive power eventhough the outer surface is flat.

As shown in FIGS. 10B and 10D, the anterior side 1004 comprises anopening 1010, which allows the insertion of an IOL as discussed herein.The opening 1010 may have sharp edges (e.g., as shown in otherimplementations herein), rounded edges (e.g., as depicted in FIGS. 10Band 10D), etc.

As shown in FIGS. 10B and 10D, the device 1000 comprises an internal lip1012. The internal lip 1012 can comprise the same options and/orfeatures as discussed herein (e.g., with respect to the lip 912). Thelip 1012 is proximate to the posterior side 1002, for example beingposterior to a plane half way between the posterior side 1002 and theanterior side 1004 and/or being posterior to the tabs 1006. Consistentwith the lip 1012 comprising the options of other lips described herein,the lip 1012 may be proximate to the anterior side 1004, proximate to amidpoint, etc., and can be based on the IOL to be inserted into thedevice 1000.

The device 1000 comprises, around a perimeter of the device 1000, afirst plurality of tabs or haptics 1006 and a second plurality of tabsor haptics 1007. The tabs 1006, 1007 can comprise the same optionsand/or features as discussed herein (e.g., with respect to the tabs906). The pluralities of tabs 1006, 1007 are not in contact and may beconsidered not continuous. The pluralities of tabs 1006, 1007 are spacedfrom each other about a perimeter of the device 1000, bunched at twoopposite sides of the device 1000. Pluralities of tabs may be bunched atone side, two sides (e.g., as shown in FIGS. 10A-10D), three sides, etc.Pluralities of tabs may be evenly circumferentially spaced (e.g., asshown in FIGS. 10A-10D) or unevenly circumferentially spaced.Pluralities of tabs may comprise the same types of tabs (e.g., as shownin FIGS. 10A-10D) or different types of tabs (e.g., comprising differentanterior-posterior bias, shape, material, absence of an opening 1008,anterior-posterior position, orientation, continuousness, combinationsthereof, and the like). Tabs within a plurality of tabs may be the sameor different (e.g., comprising different anterior-posterior bias (e.g.,as shown by the tabs 1006 a, 1006 b in the plurality of tabs 1006),shape, material, absence of an opening 1008, anterior-posteriorposition, orientation, continuousness, combinations thereof, and thelike). In implementations in which the tabs comprise circumferentiallyspaced pluralities of tabs (e.g., the tabs 1006, 1007), the tabs may beconfigured to provide more engagement (e.g., by being larger, by beingcontinuous, combinations thereof, and the like) than if the tabs extendall around the perimeter of the device. Use of fewer tabs bycircumferentially spacing pluralities of tabs 1006, 1007 may reducevolume and/or mass, which can aid insertion into small incisions (e.g.,by being easier to compress into and/or advance through an injectiondevice). Use of fewer tabs by circumferentially spacing pluralities oftabs 1006, 1007 may reduce costs due to use of less material. Asdiscussed above, tabs that are continuous may provide better appositionwith the natural capsular bag and/or be more form fitting, but haveincreased volume and/or mass. Depending on the application, the devicesdescribed herein that include tabs may include tabs that are continuous,not continuous, and combinations thereof (e.g., comprising continuoustabs over a portion of the perimeter).

The tabs 1006, 1007 are illustrated as being generally short,rounded-edge rectangular structures. Other shapes are also possible, forexample arcuate (e.g., semicircular), elongate (e.g., spiraling out ofthe device 1000), having end features (e.g., loops, hooks), etc. Whenpluralities of tabs 1006, 1007 are circumferentially spaced, theperimeter of the device 1000 may have room for more voluminous tabs1006, 1007.

As shown in FIGS. 10A, 10C, and 10D, the device 1000 comprises texturedsurfaces 1014. The textured surfaces 1014 may comprise pores (e.g.,extending partially through the walls of the device, extending fullythrough the walls of the device 1000, circular, spherical, elongate,having an undulating pattern, etc.), surface texture patterns,combinations thereof, and the like. The textured surfaces 1014 may beconfigured to capture, engage, and/or promote fibrosis (e.g., by notbeing smooth). The textured surfaces 1014 may be formed during formingthe device 1000 (e.g., by being integrated into a mold) and/or formedafter forming the device 1000 (e.g., by laser drilling). The device 1000and/or other prosthetic capsular devices may lack or be free of tabs1006, 1007, and the textured surfaces 1014 may provide engagement withthe natural capsular bag, allow fibrosis, etc. The device 1000 maycomprise tabs 1006, 1007 comprising openings or holes 1008 that mayassist in suturing the device 908, allow fibrosis therethrough, etc. andtextured surfaces 1014 that may allow fibrosis. The textured surfaces1014 of the device 1000 are positioned between the pluralities of tabs1006, 1007, but any portion of the device 1000 may comprise a texturedsurface, preferably not in the optical path, which can permit strategicfibrosis. The textured surfaces 1014 may be continuous around theperimeter, circumferentially spaced (e.g., as shown in FIG. 10C), inpatches, etc. If the device 1000 comprises tabs, the tabs may comprisetextured surfaces.

FIGS. 11A-11C and 11E illustrate still another example prostheticcapsular device 1100, in which FIG. 11A is a side view, FIG. 11B is aside cross-sectional view, FIG. 11C is a posterior plan view, and FIG.11E is an anterior side perspective view. FIG. 11D depicts a posteriorplan view of still yet another example prosthetic capsular device 1150that is similar to the device 1100 except for the refractive portion, asdescribed in further detail below. The prosthetic capsular device (e.g.,bag, bowl, housing, structure, cage, frame) 1100 does not include or isfree of a flange, although combination with a flange (e.g., the flange20) is also possible. The device 1100 comprises a posterior side 1102and an anterior side 1104.

The posterior side 1102 has a generally flat edge with a convex centralportion. As shown in FIG. 11C, convex central portion of the posteriorside 1102 comprises a refractive portion, which provides a refractiveproperty to the device 1100 for refractive powers >0 D (positive orconverging lens power). The posterior side 1102 can include a concavecentral portion for refractive powers <0 D (negative or diverging lenspower). As shown in FIG. 11C, the refractive portion of the device 1100has a diameter 1116 that is about 6 mm. As shown in FIG. 11C, therefractive portion of a similar device 1150 has a diameter 1166 that isabout 8 mm. Most IOL optics have a diameter between 5.5 mm and 6 mmsince the refractive power range of IOLs is typically ±35 D, and IOLsare designed to be substantially the same throughout the refractivepower range such that even low refractive power IOLs have a diametersimilar to that of a high refractive power IOL. The diameters of therefractive portion of the devices 1100, 1150 are not limited byrefractive power value, which can allow larger diameter refractiveportions as evidenced by the device 1150. The devices 1100, 1150 couldprovide a small refractive power value to aid an IOL, which could allowIOLs with smaller refractive powers to be used, resulting in a totalrefractive power, which could potentially increase the diameter of suchIOLs if no longer designed based on a full refractive power range. Thedevices 1100, 1150 could provide a refractive surface that hassufficient refractive power that no IOL providing additional refractivepower is inserted into device 1100, 1150.

As shown in FIGS. 11B and 11D, the anterior side 1104 comprises anopening 1110, which allows the insertion of an IOL as discussed herein.The opening 1110 may have sharp edges (e.g., as shown in otherimplementations herein), rounded edges (e.g., as depicted in FIGS. 11Band 11E), etc.

As shown in FIGS. 11B and 11E, the device 1100 lacks or is free of aninternal lip. Lack of an internal lip may reduce volume and/or mass,which can aid insertion into small incisions (e.g., by being easier tocompress into and/or advance through an injection device). Lack of aninternal lip may reduce costs due to use of less material.Alternatively, the device 1100 may comprise an internal lip, as thefeatures described with respect to the devices described in the presentapplication may be optionally substituted, interchanged, rearranged,etc. when compatible.

The device 1100 comprises, around a perimeter of the device 1100, aplurality of tabs or haptics 1106. The device 1150 comprises, around aperimeter of the device 1150, a plurality of tabs or haptics 1156. Thetabs 1106, 1156 can comprise the same options and/or features asdiscussed herein (e.g., with respect to the tabs 906, 1006, 1007). Thepluralities of tabs 1106, 1156 are not in contact and may be considerednot continuous. The tabs 1106, 1156 are not biased in an anterior and/orposterior direction, which may be easier to manufacture than biasedtabs. The tabs 1106, 1156 are larger than the tabs 906, 1006, 1007described herein. Larger tabs 1106, 1156 may increase apposition of thedevice 1100, 1150 to a natural capsular bag and/or increase fibrosissurface area. Larger tabs 1106, 1156 may also allow the formation oflarger openings 1108, 1158. Openings that extend all the way through atab, if desired, may be difficult to produce in small tabs, so thelarger tabs 1106, 1156 may enable easier formation of larger openings1108, 1158 that fully extend through the tabs 1106, 1156. Largeropenings 1108, 1158 may aid in suturing.

The prosthetic capsular devices described herein or similar prostheticcapsular devices may be compatible with any IOLs that are currentlycommercially available or developed in the future, regardless ofmanufacturer (e.g., AcrySof from Alcon, TECNIS from Abbott MedicalOptics, enVista, TRULIGN, Akreos, SofPort, and Crysalens from Bausch andLomb, iSert from Hoya Corporation, ELENZA Sapphire from Elenza, Calhounlight adjustable lens from Calhoun Vision, and others), material (e.g.,comprising PMMA, silicone, relatively hydrophobic acrylic, relativelyhydrophilic acrylic, other acrylic, collamer, combinations thereof, andthe like), product type (e.g., aphakic, pseudophakic), refractive power(e.g., negative, planar, and positive), number of pieces (e.g., one,two, three, and more), accommodation (e.g., accommodating andnon-accommodating), size (e.g., diameter, thickness), shape (e.g., disc,toroid, symmetric, and asymmetric), haptic type and quantity, deliverysystem, delivery profile, expansion profile, combinations thereof, andthe like.

Referring again to the potential advantages described above, theprosthetic capsular devices described herein or similar prostheticcapsular devices can increase the options for IOL replacement. Aphysician may be less reluctant to perform IOL replacement if theinitially-implanted lens fails due to the reduce risk of complications,such that the physician will more readily replace theinitially-implanted lens with a more appropriate lens, thereby providinga better outcome (e.g., initial outcome). Even without replacement, theIOL selection capability provided by the refractive portion of theprosthetic capsular device and/or the positioning capability provided bythe prosthetic capsular device and can improve outcome (e.g., initialoutcome). Certain prosthetic capsular devices described herein may beable to provide more accurate refractive outcomes after initial surgeryevery or almost every time.

Since IOL replacement from a prosthetic capsular device involves lessrisk than IOL replacement without a prosthetic capsular device,physicians and patients may also be more open to replacement of the IOLover time. For example, IOL replacement may be potentially advantageousfor medical reasons (e.g., due to changing physiological conditions(e.g., development of macular degeneration, glaucomatous opticneuropathy), refractive reasons (e.g., change of corneal power due tocorneal dystrophy, the progressive hyperopic shift associated withprevious refractive keratotomy), the patient's desire to access newintraocular technology (e.g., powered accommodating IOL, implantableintraocular wireless input/output computerized devices)), such thatreplacement of an IOL in a prosthetic capsular device can provideimproved outcomes even after the initial surgery. The reduced risk ofcomplications due to removal from and placement in a prosthetic capsulardevice may even permit physicians and patients to exchange the IOL asoften as desirable. The ability to change the IOL more often due to aprosthetic capsular device may also permit surgery at an earlier age, asthe physician may dispossess concerns that the initially-implanted IOLmust last the rest of the patient's life or risk serious complicationsupon replacement. Such IOL replacement procedures may even be able tosubstitute for removable corrective devices such as glasses and contactlenses.

The prosthetic capsular devices described herein or similar prostheticcapsular devices may provide a platform by which a technology device(e.g., a wearable miniaturized electronic technology device) can beinserted and carried in the eye independent of or in combination with anIOL. As used herein, the phrase “technology device” is a broad termincluding any device that generally provides biometric measurementfunctions, computer functions (e.g., digital data input directly viawireless signals and/or indirectly through sensors, data analysis,input, and/or output), image generation and projection onto the retina,and/or internet/WiFi capabilities and is small enough to fitfunctionally within the eye (e.g., having a diameter less than or equalto about 11 mm and a thickness less than or equal to about 6 mm), someof which can be used to perform useful electronic functions for thewearer. Examples of such devices include, but are not limited to,computers (e.g., Google Glass, Microsoft Hololens), virtual realitydevices, head-mounted displays (such as graphic or image displays, mapdisplays), devices with WiFi and/or internet connectivity, imagereceivers (e.g., television or movies), game devices, projectors(including image viewers, image readers, or image senders), GPS devices,biometric measurement devices (e.g., blood glucose level sensors,electrolyte sensors, heart rate sensors, basal metabolic rate sensors,temperature sensors, EEG, EKG, intraocular pressure sensors, ciliarymuscle contraction sensors, dynamic pupil change sensors), retinalprostheses, camera functions (e.g., still image and/or video recording),and e-mail senders or receivers. Such devices do not necessarily have tobe characterizeable as wearable (e.g., because they are implanted ratherthan “worn”), miniaturized (e.g., because they may have already been acertain size), or electronic (e.g., because they may be mechanical), butwould still be a “technology device” as described herein.

In use, the technology device is in the prosthetic capsular device, andthe output from the electronic device is provided to the user, eitherthrough viewing of the output visually through the eye or otherwise(e.g., wireless transmission to an external computing device). Data fromthe outside of the body can be transmitted to and/or from the technologydevice in a wireless electromagnetic energy format including, but notlimited to, currently available modalities such as Bluetooth, radiosignals, WiFi, and/or analog and/or digital cellular format signals.This data may be processed and output in the form of a visual displaythat could be projected onto the retina, creating the perception of adigital heads-up display, for example how Google Glass employed thistechnology in an external device. For technology devices configured tosense biometric data (for example, but not limited to, glucose level,electrolyte level, basal metabolic rate, temperature, EEG, EKG, heartrate, intraocular pressure (e.g., for glaucoma patients or glaucomacandidates), ciliary muscle contraction, papillary construction ordilation, eye movement, blink rate, combinations thereof, and the like),the data could be collected by the technology device and transmittedwirelessly by the technology device to an external device configured toreceive the data The electronic technology or the external device may beconfigured to process the data. For example, before transmission, thetechnology device may transform the data for privacy, security, datatransfer efficiency, etc. The external device may be configured toprocess the data, for example because the external device may moreeasily be linked to a power source, cooled, etc. The external device canbe configured to provide the data in a format that can be utilized in ahealth care decision. The data may be accessible by the wearer and/or adoctor or other healthcare professional, for example locally and/orthrough via a secure (e.g., HIPAA-compliant) network.

Another application of this technology could be use by people inenvironmentally challenging environments, for example intelligenceagents, special forces soldiers, astronauts, police officers, and/orfirefighters. Various sensors (e.g., external environmental sensors(e.g., for oxygen level, atmospheric pressure, temperature, infraredheat sensors) and/or internal biometric sensors (e.g., for oxygen level,temperature, heart rate, heart rhythm, glucose level, etc.) could becentrally assessed in an external computing device (e.g., a smartphone),and then transmitted to the intraocular lens to project information ontothe retina in a dashboard type configuration. This information could beused to help them avoid danger and/or more effectively perform theirduties. The technology could also be advantageous to performing anytasks that could benefit from a heads-up display such as surgery (e.g.,recognition and labeling of anatomical structures), mechanical repair(e.g., recognition and labeling of mechanical elements), translation(e.g., from a first language to a second language), businessidentification (e.g., based on user ratings, health ratings, etc.),directions, design, etc.

Generally, as blood glucose increases, the refractive index of theaqueous humor increases, which is optically detectable. In an exampleimplementation of an electronic device, a blood glucose monitor maycomprise an optical detector configured to monitor the refractive indexof the aqueous humor through the pupil, for example using an opticaldetector such as a camera. The refractive index may be correlated toblood glucose level via in situ electronics and/or raw data (e.g.,images, histograms, etc.) may be transmitted to an external deviceconfigured to perform the correlation. The results may be available onand/or transmitted to an external device (e.g., smartphone, smartwatch),which could trigger an alarm if the blood glucose value is above and/orbelow certain thresholds. The blood glucose value can inform the userabout the need to ingest sugar, take an insulin shot, etc. Other bodilyparameters that can be measured in the eye include, but are not limitedto, body temperature, heart rate, intraocular pressure, VEGF levels inmacular degeneration patients, diabetic retinopathy, and retinal veinocclusion. One or all of these values may be visualizable on an externaldevice (e.g., smartphone, smartwatch) and/or via an internal displaysystem (e.g., a heads-up display).

The technology device can be used in combination with an intraocularlens. For example, the technology device can be used to control theproperties of the intraocular lens (e.g., the refractive power,ultraviolet (UV) or visual light transmission properties of the IOL,etc.) and/or the properties of the prosthetic capsular device. Forexample, the technology device could be used to control the propertiesof a Calhoun adjustable lens (e.g., as described in U.S. Pat. No.7,988,285, which is hereby incorporated by reference in its entirety),an Elenza lens (e.g., as described in further detail below), etc. Whenused in combination with an IOL, the technology device and the IOL maybe positioned such that the technology device does not interfere withthe sight lines of the IOL (e.g., the technology device does not blockor interfere with light and images transmitted through the IOL and,ultimately, to the retina). The technology device may be around theoutside perimeter edge of the intraocular lens. For example, twoseparate devices, (1) an IOL and (2) the technology device, may each beattached at the outer edge of the IOL. For another example, the IOL canbe manufactured or adapted to have the technology device integral to theIOL at the outer perimeter edge of the IOL. If an IOL has a diameter ofabout 6 mm, a technology device having a width of about 2 mm may beadded around the outer perimeter of the IOL, resulting in the IOL andtechnology device having a total diameter of about 10 mm. Such devicescan vary in size, but the center is preferably at least about 1 mm toserve as the optic, and the entire device (technology device and optic)is preferably small enough to be implanted through an incision into theeye (e.g., the entire device may be similar in size to an IOL).

FIGS. 12A-12C illustrate example prosthetic capsular devices includingtechnology devices and IOLs, and a manner of positioning the technologydevice and the IOL within a prosthetic capsular device. FIG. 12A shows across-section of a ring-like technology device 1202 inside a prostheticcapsular device 1200. FIG. 12A also depicts an IOL 1204 in theprosthetic capsular device 1200. FIG. 12B depicts a front view of anexample intraocular lens 1250 usable in the example prosthetic capsulardevice 1200 shown in FIG. 12A in which the technology device 1202surrounds the outer edge of the IOL 1250 (e.g., surrounds the outer edgeof the optical surface of the IOL 1250). FIG. 12C depicts a top frontperspective of the example intraocular lens 1250. The optical surface1260 is not blocked by the technology device elements of the IOL 1250.The technology device 1202 includes an element 1252 for data output, anelement 1254 for data input or receiving, and an element 1256 for dataprocessing.

The prosthetic capsular device can comprise a material configured toshield the other internal eye structures from the small amount of heator electromagnetic waves that might be generated by the technologydevice. Examples of such materials include silicone and siliconederivatives, acrylic, acrylic derivatives, collamer, biocompatiblemethacrylates (e.g., PMMA), biocompatible polymers, olefins (e.g.,polypropylene), polyimide, combinations thereof (e.g., silicone andpolyimide), and the like. A device comprising a thermally insulatingmaterial such as silicone, polyimide, acrylic, silicon dioxide, flexibleglass, aerogels, combinations thereof (e.g., silicone and polyimide),and/or the like may be used to inhibit or prevent heat transfer due toconduction. Certain device dimensions can be increased to increase heatinsulation, although injectability concerns may also be considered. Areflective and/or opaque material such as polyimide may be used toinhibit or prevent heat transfer due to radiation. Since the device iscapsular, the device can be configured to shield (e.g., selectivelyshield) the ciliary body from heat. In some implementations, theprosthetic capsular device may comprise a combination of silicone andpolyimide (e.g., polyimide overmolded on silicone).

The prosthetic capsular device can comprise a material or have aconfiguration configured to protect the interior of the eye fromunwanted transmission of light. For example, the prosthetic capsulardevice can be designed to shield the posterior segment of the eye fromUV light (for example, therapeutic UV light that is used in highconcentration during procedures such as corneal cross-linking and in therefractive change that occurs through UV light modification of theCalhoun light adjustable lens). There are reports of retinal toxicity toUV exposure during these treatments because the pupil commonly dilatesbeyond the borders of the optic (e.g., greater than about 6 mm), and theUV filter coating on the posterior aspect of these lenses is prone tobeing rubbed off during folding and injecting, leaving the retinaexposed to high doses of UV light transmittance through areas in whichthe coating is scratched off and around the outer border between thepupil edge and the rim of the IOL. By using a prosthetic capsular devicewhich is about 10.5 mm in diameter, there would be no gap between theborder of the iris and the IOL. Other sizes of prosthetic capsulardevices can also provide UV benefits. Using established materials andmethods well known in the art of intraocular lens manufacturing, the UVchromophore could be substantially incorporated into the material of theprosthetic capsular device so this property would not be susceptible tofailure due to inadvertent mechanical removal (e.g., scratching and/orscraping off) during folding, insertion, and/or unfolding of theprosthetic capsular device.

The prosthetic capsular device can have a near-UV and UV blockingability, which can protect the eye from energy or radiation in the formof near-UV or UV light emanating from the environment and utilized fortherapeutic and refractive purposes. Intraocular lenses have been madewith coatings that include UV blocking chromaphores, which can sufferfrom scratching issues upon implantation and other issues, as describedabove. There are currently multiple ophthalmic therapies that utilize UVlight as a treatment modality. For example, the Calhoun light adjustablelens (available from Calhoun Vision, Inc. of Pasadena, Calif.) is anintraocular lens in which the refractive power can be changedpost-operatively through the targeted application of near-UV and UVlight of a specific wavelength for various time periods using aproprietary exposure algorithm. The back surface of the Calhoun lightadjustable lens has a UV blocking layer, but that UV blocking layer isprone to being mechanically damaged (e.g., rubbed or scratched off) uponinsertion of the lens, rendering the UV blocking layer potentiallyineffective such that when the near-UV or UV light treatment isperformed to adjust the lens power post-operatively, the patients areprone to near-UV and UV radiation exposure related complications to thecontents of the posterior segment (ciliary body, retina, optic nerve,etc.). The diameter of the Calhoun lens optic is 6.0 mm, which for manypatients is smaller than the dilated pupil such that UV light may passby the edges of the lens. For these patients, applying a wide beam ofnear-UV or UV light to the lens has the potential to cause UV radiationexposure related complications to the contents of the posterior segment(ciliary body, retina, optic nerve, etc.). If this light adjustable lensis placed inside a prosthetic capsular device that is larger or muchlarger than the dilated pupil and that has the ability to block near-UVand UV light, there could be a reduced likelihood of UV radiationrelated complications during the post-operative treatment.

In some implementations, a capacitor, series of capacitors, and/or arechargeable battery that can be recharged by a device from outside theeye (such as by external induction) may supply power to the technologydevice. The battery changer could be incorporated into a sleeping devicesuch as a facemask, pillow, mattress, or bed linen to charge the batteryduring a user's sleep, sunglasses, a headband, or a hat to charge thebattery while the user is outdoors, and/or spectacle frames or otherappropriate devices for when the user is indoors. Preferably, thetransfer of electricity to power a technology device either directly orthrough the charging of a battery is via an inductive charging systemsuch as through resonant inductive coupling. For example, the externaldevice could contain an induction coil and would be connected to a powersource in order to generate an alternating electromagnetic field, andthe technology device could contain a second induction coil configuredto harness power from the alternating electromagnetic field generated bythe external device and to convert the power into electricity to chargethe battery. The prosthetic capsular device can be designed to shieldthe posterior segment structures, such as the iris, zonules, ciliarybody, ciliary process, etc., from heat generated by the charging ofbatteries through external induction, or the discharge of heat generatedby a technology device, for example using certain materials andtechniques as described above. Increased local temperatures can resultin inflammation and uveitis, and ultimately limit the biocompatibilityof technology device. Utilizing a prosthetic capsular device havingoptical clarity and with thermal insulating properties (e.g., comprisingsilicone, silicone derivatives, polyimide, combinations thereof, thelike, and/or other appropriate materials) could provide appropriatethermal insulation without adversely affecting visual function.

The prosthetic capsular device can be designed to be photo-responsive soas to shield the retina from unwanted light, which could provide anumber of uses.

For a first example, people with chronic light-sensitivity may want apermanent decrease in the light transmitted. This would function likepermanent internal sunglasses. A light blocking chromophore of any andall various wavelengths, and of any and all densities of transmissioncould be added to the material formulation, baked into material,contained in a film that can be layered and bonded to the prostheticcapsular device, and/or absorbed/adsorbed into/onto the prostheticcapsular device.

For a second example, people might want to have a device in the eye thatdarkens in the light and becomes more clear/transparent in the dark(photogrey, photobrown). Photochromatic materials (e.g., silverchloride, silver halide), which change shape and light absorptionprofile in response to the presence or absence of UV light, could beadded to the material formulation, baked into material, contained in afilm that can be layered and bonded to the prosthetic capsular device,and/or absorbed/adsorbed into/onto the prosthetic capsular device.Photochromatic materials may be combined with light blockingchomophores.

For a third example, people might want to take advantage of the pinholeeffect that can be created by using a small aperture. This can beachieved by darkening all but the central 1-2 mm (approximately) of theprosthetic capsular device. This effect could be permanent (e.g.,comprising an opaque annular mask (e.g., comprising polyvinylidenefluoride (PVDF) and carbon nanoparticles) embedded in and/or on one orboth surfaces of the refractive portion) or transient (e.g., using acolor shifting and/or liquid crystal technology to create an annularmask that is opaque or has reduced transmittance). The mask could havean outer diameter between about 3 mm and about 3.5 mm (e.g., about 3.25mm). The mask could have an inner diameter between about 1 mm and about1.5 mm (e.g., about 1.35 mm). The mask could have a thickness betweenabout 4 μm and about 6 μm (e.g., about 5 μm), although thickness mayvary based on the number of masks. The mask may comprise a plurality ofmicroperforations, for example small enough to not allow substantiallight passage or to create diffractive dispersion, but removing enoughmaterial to increase flexibility of the mask. In good lighting, thepatient would be able to read due to the transient pinhole effect thatwould be created. In low lighting, the pinhole effect would be removed.Such a device could improve near and intermediate vision, increase depthof focus (e.g., by at least about 1.5 D), maintain good distance vision,inhibit creation of competing focal points, glare, halos, night-visionproblems, double vision, ghosting, etc., maintain binocularity fordistance, and/or maintain binocular contrast sensitivity.

In certain non-limiting examples, the prosthetic capsular devicesdescribed herein could perform one or more of the following functions:provide a protected prosthetic receptacle having refractive properties,for an intraocular electronic technology device having the ability tosend and receive wireless data, and/or interact with internal orexternal controls through external eye movements, pupil movement,ciliary body contraction, voice, and or controls from other prostheses(contacts, glasses, computer screens, projectors); provide a protectedprosthetic receptacle for battery storage, designed to power electronicintraocular technology; provide a protected prosthetic receptacle for anelectric powered accommodating intraocular lens (such as the Elenzalens); and/or provide a protected prosthetic receptacle for the repairor replacement of intraocular technology including traditional lenses,and electric powered devices as described above.

Referring again to FIGS. 4B-4G and the description of example animalstudy procedures, FIGS. 13A-23E are photographs of results of an animalstudy conducted along the same lines. In five rabbits, a prostheticcapsular device 400 as shown in FIGS. 4G-4I and described above, andthen an IOL (AcrySof SN60AT, a single-piece hydrophobic acrylic IOLmanufactured by Alcon) were inserted into the right eye of each rabbit,and only an IOL was inserted into the left eye of each rabbit. Theprocedure for the prosthetic capsular device and IOL eyes was asdescribed above, and the procedure for the IOL-only eyes wassubstantially the same without the prosthetic capsular device steps.

FIGS. 13A and 13B are photographs of animal study results annotated tohighlight certain features. Since the location, shading, coloration,etc. can vary based on variations in device location, lighting, anatomy,and the like, FIGS. 13A and 13B are somewhat redundantly provided toprovide the reader with the ability to identify the identified featuresin the variety of photographs described below. In FIGS. 14A-23C, fourphotographs are provided for each figure with different lightingconditions, focal points, angles, etc. to provide at least one figureillustrative of the condition of the eye; however, the photographs ineach figure are of the same eye at the same time (e.g., after one week,after two weeks, after three weeks, or after four weeks).

FIG. 13A, which is an annotated version of FIG. 18B (upper leftphotograph), illustrates an anterior capsulorhexis 4402 (shown by shortdashes), a refractive surface 4404 (shown by long dashes) of an IOL, ananterior opening 4406 (shown by intermediate dashes) of a prostheticcapsular device containing the IOL, and IOL haptics 4408. FIG. 13B,which is an annotated version of FIG. 18A (upper right photograph),illustrates an anterior capsulorhexis 4412 (shown by short dashes), arefractive surface 4414 (shown by long dashes) of an IOL, an anterioropening 4416 (shown by intermediate dashes) of a prosthetic capsulardevice containing the IOL, and IOL haptics 4418. Photographs of eyesused for control (e.g., consisting essentially of an IOL) do not show ananterior opening of a prosthetic capsular device.

Rabbit eyes are highly inflammatory such that each week in a rabbit isapproximately six months in a human. Four weeks in a rabbit, the lasttwo sets of photographs in each figure set (i.e., “D” and “E”), issubstantially equivalent to the effects after approximately two years ina human.

FIGS. 14A-14E are photographs of animal study results for a right eye ofa first rabbit. FIG. 14A is after one week, FIG. 14B is after two weeks,FIG. 14C is after three weeks, and FIGS. 14D and 14E are after fourweeks. FIGS. 14A-14E illustrate an anterior capsulorhexis 4502, arefractive surface 4504 of an IOL, an anterior opening 4506 of aprosthetic capsular device containing the IOL, and IOL haptics 4508. TheIOL haptics 4508 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics.

As described above, the natural capsular bag undergoes chronic changesafter cataract surgery believed to be largely due to the presence andcontinued growth of epithelial cells remaining on the natural capsularbag. If the entire natural capsular bag becomes fibrotic, and phimosispersists, there can be zonular dehiscence and changes to the effectivelens position over time. Significant opacification of the naturalcapsular bag may be remedied by a Nd:YAG laser posterior capsulotomy.FIGS. 14A-14C show that epithelial cell migration and propagation hasbeen successfully mediated by use of the prosthetic capsular device.Even after four weeks, the natural capsular bag is substantially free ofPCO, which is best seen by comparison to FIGS. 15A-15D, which show theleft eye of the same rabbit during the same time periods. Without beingbound by any particular theory, the Applicant believes that theprosthetic capsular device filling or substantially filling the naturalspace or volume of the natural capsular bag inhibits or prevents PCO.

FIG. 14B shows a small tear 4510 in the prosthetic capsular device atapproximately a 9 o'clock position. Even with this small defect, whichwas not present in the other four eyes containing a prosthetic capsulardevice and which is not believed to be a chronic problem, no irritationor opacification is evidenced in eyes containing a prosthetic capsulardevice. The eyes containing a prosthetic capsular device show someirritation of the vitreous.

FIG. 14E shows a Soemmering's ring 4512 and material 4514 on a posteriorsurface of the IOL. The Soemmering's ring 4512 is a toroidal collectionof lens epithelial cells that have transformed and grown after thecataract has been removed. This occurs in the natural capsular bag afterremoval of the natural lens as a result of mesenchymal epithelialtransformation thought to be caused by a combination of inflammatorymediators and contact between the anterior capsule and the posteriorcapsule.

FIGS. 15A-15E are photographs of animal study results for a left eye ofthe first rabbit. FIG. 15A is after one week, FIG. 15B is after twoweeks, FIG. 15C is after three weeks, and FIGS. 15D and 15E are afterfour weeks. FIGS. 15A-15E illustrate an anterior capsulorhexis 4602, arefractive surface 4604 of an IOL, and IOL haptics 4608. The IOL haptics4608 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics.

The first easily identifiable difference between the right eye of FIGS.14A-14D and the left eye of FIGS. 15A-15D is the significant fibrosis4612 of the natural capsular bag, even after only two weeks (FIG. 15B).Fibrosis, the epithelial-mesenchymal transition of the lens epithelialcells to muscle cells (or contractile tissue or myofibroblast tissue),can cause opacification and/or can increase the elasticity of thenatural capsular bag, which can cause contraction. Each are undesirable,but in combination, contraction and opacification can reduce an amountof light that can pass through the eye to the retina, reducing vision.

A normal eye under normal lighting conditions takes in light betweenabout 3 mm and about 6 mm. Under bright light conditions, the normal eyemay reduce light intake to between about 1 mm and about 2 mm. Under lowlight conditions, the normal eye may increase light intake to betweenabout 7 mm and about 8 mm. Due to the contraction and fibrosis, theeffective diameter at which the left eye of FIGS. 15A-15D can take inlight is about 4.1 mm, which significantly impairs the vision in thateye except under the best lighting conditions. The effective diametersprovided herein are rough approximations based on the photographs, butare precise enough to show visual impairment.

The second easily identifiable difference between the right eye of FIGS.14A-14D and the left eye of FIGS. 15A-15D is the migration or shiftingof the position of the IOL. The last figure (“E”) for each set of eyefigures, which is a gross section, best shows the centering of the IOL.The IOLs in the right eyes, which also include a prosthetic capsulardevice, were generally more centered and sat more posterior than theIOLs in the left eyes, in which the IOL is more flat in line with thecollapsed natural capsular bag.

FIG. 15E shows a Soemmering's ring 4614 and the inception of PCO 4616.As described in further detail herein, PCO is the formation of apartially opaque membrane by the reproduction of lens epithelial cellsalong the posterior of the natural capsular bag. In contrast, materialon the posterior surface, for example as described with respect to FIG.14E, is most likely retrained viscoelastic that has some residualtrapped fibrin or inflammatory precipitate contained within it.

FIGS. 16A-16E are photographs of animal study results for a right eye ofa second rabbit. FIG. 16A is after one week, FIG. 16B is after twoweeks, FIG. 16C is after three weeks, and FIGS. 16D and 16E are afterfour weeks. FIGS. 16A-16E illustrate an anterior capsulorhexis 4702, arefractive surface 4704 of an IOL, an anterior opening 4706 of aprosthetic capsular device containing the IOL, and IOL haptics 4708. TheIOL haptics 4708 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics. The IOL is well centered in the prostheticcapsular device, which can be seen by the positions of the refractivesurface 4704 of the IOL and the anterior opening 4706 of the prostheticcapsular device. In contrast to FIGS. 14A-14D, FIGS. 16A-16D, as well asFIGS. 18A-18D, 20A-20D, and 22A-22D, show that the prosthetic capsulardevice was not torn, which is generally preferably even though tearingdid not cause irritation in the eye of the first rabbit. The naturalcapsular bag is substantially free of fibrosis.

FIG. 16E shows a Soemmering's ring 4712, material 4714 on the posteriorsurface of the IOL, material 4716 attached to the posterior capsule atthe vitreous face, and the inception of peripheral PCO 4718. FIG. 16Ealso shows a mild reaction in the anterior vitreous with some smallclumps of lymphocytes 4720 in the anterior vitreous, indicative of alow-grade vitritis.

FIGS. 17A-17E are photographs of animal study results for a left eye ofthe second rabbit. FIG. 17A is after one week, FIG. 17B is after twoweeks, FIG. 17C is after three weeks, and FIGS. 17D and 17E are afterfour weeks. FIGS. 17A-17E illustrate an anterior capsulorhexis 4802, arefractive surface 4804 of an IOL, and IOL haptics 4808. The IOL haptics4808 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. As in FIGS. 46A-46E, and in stark contrast to the righteye of FIGS. 16A-16E, the left eye of FIGS. 17A-17E evidence significantfibrosis 4812 of the natural capsular bag, best seen in FIG. 17C. FIGS.15A-15E also shown contraction of the anterior capsulorhexis 4802. Dueto the contraction and fibrosis, the effective diameter at which theleft eye of FIGS. 17A-17E can take in light is about 4.3 mm, whichsignificantly impairs the vision in that eye except under the bestlighting conditions.

FIGS. 18A-18E are photographs of animal study results for a right eye ofa third rabbit. FIG. 18A is after one week, FIG. 18B is after two weeks,FIG. 18C is after three weeks, and FIGS. 18D and 18E are after fourweeks. FIGS. 18A-18E illustrate an anterior capsulorhexis 4902, arefractive surface 4904 of an IOL, an anterior opening 4906 of aprosthetic capsular device containing the IOL, and IOL haptics 4908. TheIOL haptics 4908 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics. The natural capsular bag is substantially free offibrosis. FIG. 18E shows material 4912 on a posterior surface of the IOLand the inception of peripheral PCO 4614.

FIGS. 19A-19E are photographs of animal study results for a left eye ofthe third rabbit. FIG. 19A is after one week, FIG. 19B is after twoweeks, FIG. 19C is after three weeks, and FIGS. 19D and 19E are afterfour weeks. FIGS. 19A-19E illustrate an anterior capsulorhexis 5002, arefractive surface 5004 of an IOL, and IOL haptics 5008. The IOL haptics5008 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. Out of all the left eyes, FIGS. 19A-19E show the mostdramatic contraction of the natural capsular bag, which can be seen bythe size of the anterior capsulorhexis 4902. Due to the contraction andfibrosis, the effective diameter at which the left eye of FIGS. 19A-19Ecan take in light is about 4.2 mm, which significantly impairs thevision in that eye except under the best lighting conditions. FIG. 19Ealso shows PCO.

FIGS. 20A-20E are photographs of animal study results for a right eye ofa fourth rabbit. FIG. 20A is after one week, FIG. 20B is after twoweeks, FIG. 20C is after three weeks, and FIGS. 20D and 20E are afterfour weeks. FIGS. 20A-20E illustrate an anterior capsulorhexis 5102, arefractive surface 5104 of an IOL, an anterior opening 5106 of aprosthetic capsular device containing the IOL, and IOL haptics 5108. TheIOL haptics 5108 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics. FIGS. 20A-20E show that the prosthetic capsulardevice may have been poorly centered in the natural capsular bag and/orthat the natural capsular bag contracted, but the natural capsular bagis substantially free of fibrosis such that mis-centering and/orcontraction does not present a serious issue, as light may pass throughthe still-epithelial natural capsular bag cells. FIG. 20E shows material5112 on a posterior surface of the IOL. The right eye of the fourthrabbit also shows a small amount of fibrin peripherally between theprosthetic capsular device and the IOL, discussed in further detailbelow.

FIGS. 21A-21E are photographs of animal study results for a left eye ofthe fourth rabbit. FIG. 21A is after one week, FIG. 21B is after twoweeks, FIG. 21C is after three weeks, and FIGS. 21D and 21E are afterfour weeks. FIGS. 21A-21E illustrate an anterior capsulorhexis 5202, arefractive surface 5204 of an IOL, and IOL haptics 5208. The IOL haptics5208 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. Like several of the other left eyes, FIGS. 21A-21E showsignificant fibrosis and contraction. Due to the contraction andfibrosis, the effective diameter at which the left eye of FIGS. 21A-21Ecan take in light is about 2.6 mm, which significantly impairs thevision in that eye except under the best lighting conditions. FIG. 21Ealso shows PCO.

FIGS. 22A-22E are photographs of animal study results for a right eye ofa fifth rabbit. FIG. 22A is after one week, FIG. 22B is after two weeks,FIG. 22C is after three weeks, and FIGS. 22D and 22E are after fourweeks. FIGS. 22A-22E illustrate an anterior capsulorhexis 5302, arefractive surface 5304 of an IOL, an anterior opening 5306 of aprosthetic capsular device containing the IOL, and IOL haptics 5308. TheIOL haptics 5308 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics Like FIGS. 18A-18E, FIGS. 22A-22E show goodcentering of the prosthetic capsular device in the natural capsular bag,and lack of fibrosis. FIG. 22E shows material 5312 on a posteriorsurface of the IOL and peripheral PCO 5314.

FIGS. 23A-23E are photographs of animal study results for a left eye ofthe fifth rabbit. FIG. 23A is after one week, FIG. 23B is after twoweeks, FIG. 23C is after three weeks, and FIGS. 23D and 23E are afterfour weeks. FIGS. 23A-23E illustrate an anterior capsulorhexis 5402, arefractive surface 5404 of an IOL, and IOL haptics 5408. The IOL haptics5408 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. Like several of the other left eyes, FIGS. 21A-21E showsignificant fibrosis and contraction. Due to the contraction andfibrosis, the effective diameter at which the left eye of FIGS. 23A-23Ecan take in light is about 4.5 mm, which significantly impairs thevision in that eye except under the best lighting condition.

The reduction in the effective diameter shows why PCO can be sodetrimental and preferably reduced or prevented. As described above, aNd:YAG laser may be used to ablate the natural capsular bag to removethe opaque membrane. If the natural capsular bag separating the vitreousis removed, then post-PCO treatment operation on an IOL absent aprosthetic capsular device could result in anterior flow of vitreous. Acareful user may be able to viscodissect an IOL from an eye and place aprosthetic capsular device comprising a posterior surface into the eyeto inhibit or prevent the flow of vitreous. The eye of a post-PCOsubject with an existing IOL issue may be salvageable using a prostheticcapsular device, providing another potential advantage and/or use.

One goal of the animal studies of FIGS. 14A-23E was to show that use ofa prosthetic capsular device was not worse for the eye than use of anIOL alone. The right eyes were all substantially free of fibrosis (e.g.,almost totally pristine), IOL position shift, and anterior capsulorhexiscontraction. By contrast, the left eyes generally showed significantfibrosis, IOL migration, and significant asymmetric contraction of thecapsulorhexis. The animal studies empirically show that the use of aprosthetic capsular device can provide at least some of the advantagesdiscussed herein.

Slight damage to the prosthetic capsular devices such as small tears inthe edge of the anterior opening may have occurred due to insertionthrough the Accuject 2.2 mm injectors. Upon any incomplete injection ofthe prosthetic capsular device into the natural capsular bag, theprosthetic capsular device was manipulated with a collar button hookafter injection to complete in-the-bag fixation. The manipulation and/ora hard push on the injector may have caused the damage. Injection of theprosthetic capsular device fully into the natural capsular bag (e.g.,without further manipulation or repositioning), for example using adifferent injector, may reduce the risk of tearing the prostheticcapsular device.

Inflammation of the vitreous in right eyes, starting after about twoweeks and then decreasing throughout the follow up, may have been due tothe material of the prosthetic capsular device being sterilized, but nothaving undergone an extensive extraction process such that uncrosslinkedsiloxane monomers can leach out of the material over time. Extractionprior to sterilization and packaging of the prosthetic capsular device,for example single, double, triple, or more extractions to promotecrosslinking (e.g., substantially total crosslinking), may reduce suchinflammation.

Fibrin formation between the prosthetic capsular device and the IOL mayhave been due to incomplete viscoelastic removal and/or residual OVDremained trapped behind the IOL. More aggressive viscoelastic evacuationafter the implantation, use of a more cohesive viscoelastic material,which may be easier to remove than dispersive viscoelastic materials,and/or an OVD removal technique may reduce the such fibrin formation.There was little change in the fibrin material throughout the fourweeks. Fibrin was also generally observed at the level of thecapsulorhexis edge in the left eyes, which was resolved within twoweeks.

Dilation or significant dilation of the natural capsular bag wasgenerally associated with the presence of the prosthetic capsulardevice. However, ACO was absent, for example due to lack of contactbetween the residual anterior capsule and the anterior surface of theprosthetic capsular device, such that the dilation was not a negativeresult.

The right eyes, in which a prosthetic capsular device was placed beforean IOL, showed significantly reduced Soemmering's ring formationcompared to the left eyes, in which only an IOL was placed. The righteyes showed reduced central and peripheral PCO compared to the lefteyes. A different edge profile (e.g., square) of a prosthetic capsulardevice, for example as described herein, may provide a better effectagainst PCO. PCO at week 4 of the examination was scored as a 0 in theright eyes and as 2±1 in the left eyes (two-tail P=0.01; t-Test: PairedTwo Sample for Means). ACO was found to be absent in the right eyes andwas mile (0.5 or 1) in the left eyes.

Central PCO was scored (two-tail P=0.05; t-Test: Paired Two Sample forMeans,) as 0.1±0.22 for right eyes and 1.2±0.75 for left eyes.Peripheral PCO was scored (two-tail P=0.23; t-Test: Paired Two Samplefor Means) as 0.8±0.83 for right eyes and 1.8±0.83 for left eyes; theamount of PCO varied from a trace to moderate PCO. Soemmering's ringformation was scored (two-tail P=0.006; t-Test: Paired Two Sample forMeans) as 2.8±0.83 for right eyes and 8.6±2.19 for left eyes; the lefteyes all showed a moderate Soemmering's ring formation withproliferation of cortical material in the periphery. In all cases, alower number indicates better results. In all parameters, eyes with aprosthetic capsular device scored better than eyes without a prostheticcapsular device.

All prosthetic capsular devices were found to be fully fixated inside ofthe natural capsular bag and centered. The IOL in FIGS. 14A-14E was veryslightly decentered inside of the prosthetic capsular device. Mild IOLdecentration (0.5 or 1) inside of the prosthetic capsular bag wasobserved in two left eyes.

There was no sign of untoward inflammation or toxicity on any of theleft eyes. There was no sign of any toxicity or inflammation on four ofthe five right eyes. As mentioned above with respect to FIG. 16E, oneright eye showed a mild anterior vitritis.

Referring again to the disclosure regarding use of the technology deviceto control the properties of an IOL, FIG. 24A is a flowchart of anexample of controlling focus of an IOL using an external device.Starting at block 5500, the external device receives input from a userat block 5502. An example of user input is control of an external device(e.g., external to the eye) such as a smartwatch, smartphone, and thelike. In some implementations, control of the external device is with asecond external device. For example, a user wearing a ring on one handmay touch a smartwatch worn on the opposite wrist to complete a circuit,send a signal (e.g., via near-field communication (NFC)), or otherwisecommunicate. In some implementations, the user operation 5502 does notrequire full attention of the user (e.g., attention to a display) suchthat the focus can be controlled without the user deviating from anotheractivity such as driving or communicating with someone. For example, auser may initiate an operation by a series of taps on a smartwatch or avoice command based on built-in voice recognition such as Siri on Appledevices or OK Google on Android devices. In some implementations,features of a smartphone (e.g., volume buttons) and/or a smartwatch(e.g., a rotatable knob) can be manipulated, which may provide finetuning of and/or adjusting of the focus. Operation of a softwareapplication running on an external device that is configured to controlthe IOL is also possible.

Upon receipt of the user input at block 5502, the external devicewirelessly transmits an electronic message at block 5504 to the IOL. Thewireless transmission may be in accordance with a standard wirelessprotocol such as Bluetooth or a specialized wireless protocol, forexample to enhance security and/or safety. As described above, theexternal device may be a single device or a series of devices operatingin conjunction with each other. For example, the external device thatemits the wireless transmission at block 5504 may be a smartwatch. Foranother example, the external device that emits the wirelesstransmission at block 5504 may be a smartphone that received a firstwireless transmission from a smartwatch. The wireless transmission isconfigured to be received by a technology device and/or an IOLconfigured to process the wireless transmission and cause focusadjustment.

In some implementations, the wireless transmission is received by thetechnology device of the prosthetic capsular device, which then controlsoperation of an adjustable-focus IOL in the prosthetic capsular device.In some implementations, the wireless transmission is received by theadjustable-focus IOL in the prosthetic capsular device directly (e.g.,if the prosthetic capsular device lacks a suitable technology device orany technology device, or in the absence of the use of a prostheticcapsular device for suitable IOLs). In some implementations, thewireless transmission is received by another device that communicateswith the technology device of the prosthetic capsular device and/or theadjustable-focus IOL in the prosthetic capsular device. For example, thesmartwatch may send a wireless transmission to a smartphone, which emitsa secondary wireless transmission that may be received by the IOL, thetechnology device, etc. One or more of the wireless transmissions may besent over a network. Intraocular communication may be wireless (e.g.,based on the same or different wireless standard) or wired (e.g., basedon electrical contact between an exterior of the IOL haptics and aninterior of the prosthetic capsular device).

In response to the wireless transmission or a secondary wirelesstransmission, the IOL focus adjusts at block 5506. The block 5506 isshown in dashed outline because the process may be performed by anotherdevice (e.g., the IOL). The focus may adjust for near objects byincreasing refractive power (e.g., to allow the user to focus on nearobjects) and/or adjust for intermediate to distance vision by decreasingrefractive power (e.g., to allow the user to focus on intermediateand/or distant objects).

An example of an IOL that may be focus adjusted at block 5504 is ELENZASapphire from Elenza. Upon sensing a change in the natural pupil, theElenza IOL can accommodate, or focus. For example, upon sensing that thenatural pupil is constricting, the Elenza IOL can myopicallyaccommodate. As another example, upon sensing that the natural pupil isdilating, an IOL may return to the dis-accommodated state foremmetropia. As another example, upon sensing that the natural pupil isdilating, an IOL may return adjust focus for intermediate and/or distantobject viewing. In some implementations, the transmission at block 5506may effect accommodation regardless of a state of the natural pupil. Insome implementations, the transmission at block 5506 may effectaccommodation in combination with sensing of a change in a naturalpupil.

Another example of focus adjustment at block 5504 is by a technologydevice comprising an artificial pupil or electronically-controlled irisdiaphragm configured to selectively block light transmission into theeye. The transmission at block 5506 can instruct the artificial pupil toconstrict and/or dilate. In some implementations, an artificial pupilcould effectively work for patients with damaged or missing iris tissueand/or to provide increased depth of focus, creating a hyperfocality bydecreasing the effective aperture size. In some implementations, anartificial pupil allows the user to achieve better near and intermediatevision in adequate lighting, without the loss of distance vision. Anexample of a static device that could achieve these refractive benefitsis the Acufocus Kamra. This device is typically implanted either in thecornea or upon an IOL, and heretofore not been controllable by the user,for example in a manner that can increase or optimize functionality. Insome implementations, upon application of an electrical wirelesstransmission, the technology device works similarly to a cameraaperture, closing circumferentially from the limbal toward the visualaxis. In some implementations, upon application of an electricalwireless transmission, the molecular configuration of liquid crystals inthe technology device orient to make an edge opaque, akin to the resultof pupil constriction. The artificial pupil may work in combination withthe natural pupil, or may provide beneficial refractive effectsindependent of the natural pupil. In some implementations, an artificialpupil may work in combination with accommodation of an IOL such as theElenza IOL. In some implementations, a technology device of theprosthetic capsular device comprises the artificial pupil, which may beused in combination with an IOL, an accommodating IOL, or without anIOL.

Another example of an IOL that may be focus adjusted at block 5504 isLight Adjustable Lens (LAL) from Calhoun Vision that has not been lockedin. Upon application of an electrical wireless transmission, light isdirected to cause photopolymerization of macromers and swelling in anilluminated area, causing a change in power. The focus of the IOL may bechanged using a microsolenoid (e.g., application of an electricalwireless transmission to a coil creates a magnetic field that attractsor repels a magnetic material coupled to a refractive surface), MEMS(e.g., application of an electrical wireless transmission creates anelectrostatic charge that attracts a hinged metallic material coupled toa refractive surface), etc. The entire IOL or portions thereof (e.g., arefractive surface) may move within the prosthetic capsular device,providing a focusing mechanism to non-adjustable IOLs.

In some implementations, the IOL and/or the technology device may send awireless transmission, command instruction, computer-generated message,or the like to the external device to confirm that focus adjusted.Although the focus adjustment may be visible to a user, such feedbackmay aid in initial setup, calibration, troubleshooting, etc. In certainsuch implementations, the process may optionally further comprisereceipt of a confirmation wireless transmission by the external devicethat the focus was adjusted.

The external device may optionally be configured to receive otherwireless transmissions from the IOL and/or the technology device (e.g.,low battery, error codes, limits reached, etc.). In certain suchimplementations, the emission of the wireless transmission by theexternal device 5504 may be based on confirmation that the IOL is ableto focus in accordance with the wireless transmission. The externaldevice may optionally be configured to receive other wirelesstransmissions from the IOL and/or the technology device other thanregarding focus, for example as described in further detail herein.

The process ends at block 5508. The focus of the IOL may revert aftersome amount of time or in response to a second wireless transmissionfrom the external device (e.g., upon receipt of a second user input).Some of the processes discussed above and other processes are describedin more detail with respect to FIGS. 24B-24F.

FIG. 24B is a schematic of a system for controlling an electronic device(e.g., technology device and/or an IOL) using an external device. In theillustrated flowchart, a prosthetic capsular device 5510 includes atechnology device. The prosthetic capsular device 5510 at leastpartially contains an IOL 5512. The technology device of the prostheticcapsular device 5510 and/or the IOL 5512 is in communication with aprimary external device 5514. The primary external device 5514 maycomprise, for example, a smartphone, a smartwatch, etc. The primaryexternal device 5514 is optionally in communication with a secondaryexternal device 5516. The secondary external device 5516 may comprise,for example, a smartwatch (e.g., in combination with the primaryexternal device 5514 comprising a smartphone). The secondary externaldevice 5516 is optionally in communication with a tertiary externaldevice 5518. The tertiary external device 5518 may comprise, forexample, a ring (e.g., in combination with the secondary external device5516 comprising a smartwatch). The primary external device 5514, thesecondary external device 5516, and the tertiary external device 5518may act singly, in subcombination, or in full combination to, interalia, receive input by a user and emit a wireless transmission to thetechnology device of the prosthetic capsular device 5510 and/or the IOL5512. Additional external devices (e.g., quartenary, quinary, etc.) arealso possible.

FIG. 24C is a flowchart of an example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Starting at block 5520, the external device receivesinput from a user at block 5522. Upon receipt of the user input at block5522, the external device processes the user input at block 5524. Theexternal device may include a processing module, a static memory module,a dynamic or temporary memory module, a power source, a user inputreceipt module, a wireless transmission emitting module, a wirelesstransmission receiving module, and the like. Upon processing of the userinput at block 5524, the external device generates an instructioncommand for transmission to an electronic device (e.g., a technologydevice of a prosthetic capsular device, an IOL, etc.) implanted in theeye at block 5526. The generation of the instruction command may beautomatic upon receipt and processing of the user input, or may includefurther interaction with the user or another device. The instructionsmay include, for example, to focus the IOL. Upon generation of theinstruction command at block 5526, the external device may optionallyreceive confirmation and/or a current status input from the electronicdevice (e.g., a technology device of a prosthetic capsular device, anIOL, etc.) implanted in the eye at block 5528. Depending on generationof the instruction command and/or receipt of the confirmation and/orcurrent status input from the electronic device, the process may repeatstarting at block 5522 or end at block 5530.

FIG. 24D is a flowchart of another example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Referring to FIG. 24B, for example, the external devicecomprises a primary external device (e.g., a smartphone) and a secondaryexternal device (e.g., a smartwatch). Starting at block 5532, thesecondary external device receives input from a user at block 5534. Uponreceipt of the user input at block 5534, the primary external devicereceives the user input from the secondary external device at block5536. The primary external device may be in wired or wirelesscommunication with the secondary external device so as to receive theuser input directly or as a result of a wireless transmission from thesecondary external device. Upon receipt of the user input at block 5536,the primary external device processes the user input at block 5538. Uponprocessing of the user input at block 5538, the primary external devicegenerates an instruction command for transmission to an electronicdevice (e.g., a technology device of a prosthetic capsular device, anIOL, etc.) implanted in the eye at block 5540. The generation of theinstruction command may be automatic upon receipt and processing of theuser input, or may include further interaction with the user, thesecondary external device, another device, etc. The instructions mayinclude, for example, to focus the IOL. Upon generation of theinstruction command at block 5540, the primary external device mayoptionally receive confirmation and/or a current status input from theelectronic device (e.g., a technology device of a prosthetic capsulardevice, an IOL, etc.) implanted in the eye at block 5542. The primaryexternal device and/or the secondary external device may optionallydisplay the confirmation and/or current status input at block 5544.Depending on generation of the instruction command, receipt of theconfirmation and/or current status input from the electronic device,and/or display of the confirmation and/or current status input, theprocess may repeat starting at block 5534 or end at block 5546.

FIG. 24E is a flowchart of another example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Referring to FIG. 24B, for example, the external devicecomprises a primary external device (e.g., a smartphone) and a secondaryexternal device (e.g., a smartwatch). Starting at block 5550, thesecondary external device receives input from a user at block 5552. Uponreceipt of the user input at block 5552, the primary external devicereceives the user input from the secondary external device at block5554. The primary external device may be in wired or wirelesscommunication with the secondary external device so as to receive theuser input directly or as a result of a wireless transmission from thesecondary external device. Upon receipt of the user input at block 5554,the primary external device processes the user input at block 5556. Uponprocessing of the user input at block 5556, the primary external devicegenerates an instruction command for transmission to an electronicdevice (e.g., a technology device of a prosthetic capsular device, anIOL, etc.) implanted in the eye at block 5558. The generation of theinstruction command may be automatic upon receipt and processing of theuser input, or may include further interaction with the user, thesecondary external device, another device, etc. The instructions mayinclude, for example, to focus the IOL.

FIG. 24E includes a dashed horizontal line indicative of processes thatmay be performed by the electronic device (e.g., a technology device ofa prosthetic capsular device, an IOL, etc.) implanted in the eye. Itwill be appreciated that the electronic device may be separate from theexternal device, and that the processes described with respect to FIG.24E are examples for reference only. In some implementations, theexternal device and the electronic device form a system or kit.

The electronic device may receive the instruction command at block 5560.Upon receipt of the instruction command at block 5560, the electronicdevice may process the instruction command at block 5562. Uponprocessing of the instruction command at block 5562, the electronicdevice may adjust a parameter of the electronic device based on theinstruction command at block 5564. The adjustment of the parameter maybe automatic upon receipt and processing of the instruction command, ormay include further interaction with the user, the primary externaldevice, the secondary external device, and/or another device, analysisof the parameter and/or another parameter, etc. The parameter mayinclude, for example, IOL focus (e.g., an amount of masking, an amountof movement, an amount of rotation, etc.). Upon adjustment of theparameter at block 5564, the electronic device may generate confirmationand/or a current status output at block 5566. The electronic device mayperform more, fewer, different, differently ordered, etc. processes, mayinclude interaction between multiple electronic devices (e.g., between atechnology device of a prosthetic capsular device and an IOL), etc.

The primary external device may optionally receive confirmation and/or acurrent status input (generated as output) from the electronic deviceimplanted in the eye at block 5568. The primary external device and/orthe secondary external device may optionally display the confirmationand/or current status input at block 5570. The process ends at block5572.

FIG. 24F is a flowchart of another example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Referring to FIG. 24B, for example, the external devicecomprises a primary external device (e.g., a smartphone) and a secondaryexternal device (e.g., a smartwatch). Starting at block 5574, thesecondary external device receives input from a user at block 5576. Uponreceipt of the user input at block 5576, the primary external devicereceives the user input from the secondary external device at block5578. The primary external device may be in wired or wirelesscommunication with the secondary external device so as to receive theuser input directly or as a result of a wireless transmission from thesecondary external device.

The primary external device determines the user input at block 5580. Inthe event of a first user input, the primary external device generatesan instruction command to change focus to near objects (e.g., myopicaccommodation as described herein with respect to the Elenza IOL) atblock 5582. In the event of a second user input different than the firstuser input, the primary external device generates an instruction commandto change focus to intermediate and/or distant objects (e.g., emmetropiaor a dis-accommodated state as described herein) at block 5584. Forclarity, the Elenza IOL uses pupillary constriction as a sign that theeye is trying to accommodate (focus) and the lens changes focus based onthe natural pupillary constriction. That is, the Elenza IOL does notcause the pupil to constrict and does not contain a prosthetic irisdevice. In some implementations, instruction commands described hereincould, for example, cause the Elenza IOL to change focus regardless ofconstriction of the natural pupil.

In some implementations, for example using an IOL other than an ElenzaIOL or by way of a technology device of a prosthetic capsular device, aninstruction command could, for example, effect constriction or dilationof an artificial pupil.

Focus adjustment of an Elenza IOL and constriction/dilation of anartificial pupil and are provided as example parameter changes, and itwill be appreciated that other parameter changes based on differentinputs is also possible. The generation of the instruction commands maybe automatic upon receipt and processing of the user input, or mayinclude further interaction with the user (e.g., instruction command incombination with sensing of natural pupil dilation), the secondaryexternal device, another device, etc. In some implementations, thesecondary external device may determine the user input and the primaryexternal device may receive an instruction command.

Upon generation of the instruction command at block 5582 or 5584, theprimary external device transmits the instruction command to anelectronic device (e.g., a technology device of a prosthetic capsulardevice, an IOL, etc.) implanted in the eye at block 5586. Theinstructions may include, for example, to focus the IOL. Upontransmission of the instruction command at block 5586, the primaryexternal device may optionally receive confirmation and/or a currentstatus input from the electronic device (e.g., a technology device of aprosthetic capsular device, an IOL, etc.) implanted in the eye at block5588. The primary external device and/or the secondary external devicemay optionally display the confirmation and/or current status input atblock 5590. The process ends at block 5592.

FIG. 25 is a block diagram depicting an example computer hardware systemconfigured to execute software for implementing one or moreimplementations of electronic device control disclosed herein In someimplementations, the hardware systems and/or devices described abovetake the form of a computing system 5600, which is a block diagram ofone implementation of a computing system that is in communication withone or more computing systems 5618 and/or one or more data sources 5620via one or more networks 5616. The computing system 5600 may be used toimplement one or more of the systems and methods described herein. Insome implementations, the computing system 5600 is configured to manageaccess or administer a software application. While FIG. 25 illustratesan example computing system 5600, it is recognized that thefunctionality provided for in the components and modules of thecomputing system 5600 may be combined into fewer components and modulesor further separated into additional components and modules.

Electrical System

In some implementations, the computing system 5600 comprises anelectrical system 5606 configured to carry out one or more of thefunctions described herein with reference to control of an electronicdevice implanted in an eye, including any one of techniques describedabove. The electrical system 5606 and/or other modules may be executedon the computing system 5600 by a central processing unit 5602 discussedfurther below.

In general, the word “module,” as used herein, refers to logic embodiedin hardware or firmware, or to a collection of software instructions,possibly having entry and exit points, written in a programminglanguage, such as, for example, COBOL, CICS, Java, Lua, C or C++. Asoftware module may be compiled and linked into an executable program,installed in a dynamic link library, or may be written in an interpretedprogramming language such as, for example, BASIC, Perl, or Python. Itwill be appreciated that software modules may be callable from othermodules or from themselves, and/or may be invoked in response todetected events or interrupts. Software instructions may be embedded infirmware, such as an EPROM. It will be further appreciated that hardwaremodules may be comprised of connected logic units, such as gates andflip-flops, and/or may be comprised of programmable units, such asprogrammable gate arrays or processors. The modules described herein arepreferably implemented as software modules, but may be represented inhardware or firmware. Generally, the modules described herein refer tological modules that may be combined with other modules or divided intosub-modules despite their physical organization or storage.

Computing System Components

The computing system 5600 can comprise a central processing unit (CPU)5602, which may comprise a conventional microprocessor. The computingsystem 5600 further comprises a memory 5604, such as random accessmemory (RAM) for temporary storage of information and/or a read onlymemory (ROM) for permanent storage of information, and a mass storagedevice 5608, such as a hard drive, diskette, or optical media storagedevice. In some implementations, the modules of the computing system5600 are connected to the computer using a standards based bus system.In some implementations, the standards-based bus system could includePeripheral Component Interconnect (PCI), Microchannel, SCSI, IndustrialStandard Architecture (ISA) and Extended ISA (EISA) architectures, forexample.

The computing system 5600 comprises one or more commonly availableinput/output (I/O) devices and interfaces 5612, such as a keyboard,mouse, touchpad, touchscreen, ring, printer, etc. In someimplementations, the I/O devices and interfaces 5612 comprise one ormore display devices, such as a monitor or touchscreen, that allows thevisual presentation of data to a user. A display device can provide forthe presentation of graphical user interfaces (GUI), applicationsoftware data, and multimedia presentations, for example. In someimplementations, the I/O devices and interfaces 5612 comprise amicrophone, motion, and/or NFC sensor that allows a user to generateinput to the computing system 5600 using sounds, voice, motion,gestures, or the like. In FIG. 25, the I/O devices and interfaces 5612also provide a communications interface to various external devices viaa link 5614 to the network 5616. The computing system 5600 may alsocomprise one or more multimedia devices 5610, such as speakers, videocards, graphics accelerators, and microphones, for example.

Computing System Device/Operating System

The computing system 5600 may run on a variety of computing devices,such as, for example, a specifically designed device, a server, aWindows server, a Structure Query Language server, a Unix server, apersonal computer, a mainframe computer, a laptop computer, a tabletcomputer, a cell phone, a smartphone, a smartwatch, a personal digitalassistant, a kiosk, an audio player, an e-reader device, and so forth.The computing system 5600 is generally controlled and coordinated byoperating system software, such z/OS, Windows 95, Windows 98, WindowsNT, Windows 2000, Windows XP, Windows Vista, Windows 7, Windows 8,Linux, BSD, SunOS, Solaris, Android, iOS, BlackBerry OS, or othercompatible operating systems. In Macintosh systems, the operating systemmay be any available operating system, such as MAC OS X. In someimplementations, the computing system 5600 is controlled by aproprietary operating system. The operating system may, for example,control and schedule computer processes for execution, perform memorymanagement, provide file system, networking, and I/O services, andprovide a user interface, such as a GUI, among other things.

Network

FIG. 25 illustrates the computing system 5600 is coupled to an optionalnetwork 5616, such as a LAN, WAN, or the Internet, for example, via awired, wireless, or combination of wired and wireless, communicationlink 5614. The network 5616 communicates with various computing devicesand/or other electronic devices via wired or wireless communicationlinks. In FIG. 25, the network 5616 is communicating with one or morecomputing systems 5618 and/or one or more data sources 5620.

Access to the electrical system 5606 of the computer system 5600 bycomputing systems 5618 and/or by data sources 5620 may be through aweb-enabled user access point such as the computing systems' 5618 ordata source's 5620 personal computer, mobile device, cellular phone,smartphone, smartwatch, laptop, tablet computer, e-reader device, audioplayer, or other device capable of connecting or configured to connectto the network 5616. Such a device may have a browser module or specificapplication that is implemented as a module that uses text, graphics,audio, video, and other media to present data and to allow interactionwith data via the network 5616.

The browser module or specific application may be implemented as acombination of an all points addressable display such as a cathode-raytube (CRT), a liquid crystal display (LCD), a plasma display, or othertypes and/or combinations of displays. The browser module or specificapplication may be implemented to communicate with input devices 5612and may comprise software with the appropriate interfaces to allow auser to access data through the use of stylized screen elements such as,for example, menus, windows, dialog boxes, toolbars, and controls (forexample, radio buttons, check boxes, sliding scales, and so forth). Thebrowser module may communicate with a set of input and output devices toreceive wireless transmissions from the user.

The input device(s) may comprise a keyboard, roller ball, pen andstylus, mouse, ring, smartwatch, knob, trackball, voice recognitionsystem, or pre-designated switches or buttons. The output device(s) maycomprise a speaker, a display screen, a printer, or a voice synthesizer.A touch screen may act as a hybrid input/output device. In someimplementations, a user may interact with the system through a systemterminal without communications over the Internet, a WAN, or LAN, orsimilar network.

In some implementations, the system 5600 comprises a physical or logicalconnection between a remote microprocessor and a mainframe host computerfor the purpose of uploading, downloading, or viewing interactive dataand databases on-line in real time. The remote microprocessor may beoperated by an entity operating the computer system 5600, including theclient server systems or the main server system, an/or may be operatedby one or more of the data sources 5620 and/or one or more of thecomputing systems 5618. In some implementations, terminal emulationsoftware may be used on the microprocessor for participating in themicro-mainframe link.

In some implementations, computing systems 5618 that are internal to anentity operating the computer system 5600 may access the electricalsystem 5606 internally as an application or process run by the CPU 5602.

User Access Point

In some implementations, a user access point or user interface comprisesa personal computer, a laptop computer, a tablet computer, an e-readerdevice, a mobile device, a cellular phone, a smartphone, a smartwatch, aGPS system, a Blackberry® device, a portable computing device, a server,a computer workstation, a local area network of individual computers, aninteractive kiosk, a personal digital assistant, an interactive wirelesscommunications device, a handheld computer, an embedded computingdevice, an audio player, or the like.

Other Systems

In addition to the systems illustrated and described above, the network5616 may communicate with other data sources and/or other computingdevices. The computing system 5600 may comprise one or more internaland/or external data sources. In some implementations, one or more ofthe data repositories and the data sources may be implemented using arelational database, such as DB2, Sybase, Oracle, CodeBase, Microsoft®SQL Server, as well as other types of databases such as, for example, aflat file database, an entity-relationship database, and object-orienteddatabase, and/or a record-based database.

EXAMPLE EMBODIMENTS

The following example embodiments identify some possible permutations ofcombinations of features disclosed herein, although other permutationsof combinations of features are also possible.

1. A prosthetic capsular device system configured to be inserted in aneye, the system comprising:

-   -   prosthetic capsular device comprising:        -   an anterior surface including an opening, and        -   a posterior surface, at least a portion of the posterior            surface comprising a refractive surface; and    -   a technology device.

2. The system of embodiment 1, further comprising an intraocular lenspositioned such that the technology device does not substantiallyinterfere with sight lines through the intraocular lens.

3. The system of embodiment 2, wherein the technology device isconfigured to control a property of the intraocular lens.

4. The system of embodiment 3, wherein the controlled property of theintraocular lens includes at least one of: refractive capabilities,light transmission, UV transmission, and accommodative properties.

5. The system of any one of embodiments 2-4, wherein the technologydevice forms an integral part of the intraocular lens, and wherein thetechnology device surrounds all or part of an outer perimeter edge ofthe intraocular lens.

6. The system of any one of embodiments 1-5, wherein the technologydevice comprises at least one of a computer, a virtual reality device, adisplay device, an internet access device, a receiver, a game device, animage viewer, a projector, a global positioning system, an e-maildevice, and a biometric sensor device.

7. The system of embodiment 6, wherein the receiver comprises a digitaldata receiver.

8. The system of any one of embodiments 1-7, wherein the technologydevice comprises a power source capable of being recharged from outsidethe eye.

9. The system of any one of embodiments 1-8, wherein the prostheticcapsular device comprises an exterior contour configured to mechanicallymaintain the prosthetic capsular device at a specific position withinthe eye.

10. The system of embodiment 9, wherein the exterior contour isconfigured to extend into a ciliary sulcus.

11. The system of any one of embodiments 9 and 10, wherein the exteriorcontour comprises a flange extending radially outwardly from theopening.

12. The system of any one of embodiments 1-11, wherein the refractivesurface includes at least one of the following optical and designqualities: concave, convex, spherical, aspheric, wavefront, multifocaldiffractive, multifocal refractive, multifocal zonal, accommodative, UVfiltering, diffractive chromatic aberration reducing, and astigmatismcorrecting tonic form.

13. The system of any one of embodiments 1-12, wherein the technologydevice is configured to control at least one of the following propertiesof the prosthetic capsular device: light transmission, UV transmission,and heat insulation.

14. A method of operating on an eye, the method comprising:

-   -   inserting a prosthetic capsular device in the eye, the        prosthetic capsular device including:        -   an anterior surface including an opening, and        -   a posterior surface, at least a portion of the posterior            surface comprising a refractive surface; and    -   inserting a technology device in the prosthetic capsular device.

15. The method of embodiment 14, wherein the technology device comprisesat least one of a computer, a virtual reality device, a display device,an internet access device, a receiver, a game device, an image viewer, aprojector, a global positioning system, an e-mail device, and abiometric sensor device.

16. The method of any one of embodiments 14 and 15, further comprisinginserting an intraocular lens in the prosthetic capsular device, whereinafter inserting the intraocular lens the technology device does notsubstantially interface with sight lines through the intraocular lens.

17. The method of any one of embodiments 14-16, wherein the technologydevice is configured to control one or more properties of theintraocular lens.

18. The method of embodiment 17, wherein the controlled properties ofthe intraocular lens includes at least one of: refractive capabilities,light transmission, UV transmission, and accommodation properties.

19. The method of any one of embodiments 16-18, wherein the technologydevice forms an integral part of the intraocular lens, and wherein thetechnology device surrounds all or part of an outer perimeter edge ofthe intraocular lens.

20. The method of any one of embodiments 14-19, wherein the technologydevice comprises a power source capable of being recharged from outsidethe eye.

21. The method of any one of embodiments 14-20, wherein inserting theprosthetic capsular device comprises inserting the prosthetic capsulardevice in a natural capsular bag of the eye.

22. The method of embodiment 21, further comprising, before insertingthe prosthetic capsular device, removing a natural lens from the naturalcapsular bag, the natural lens including a posterior surface at alocation in the natural capsular bag before removing the natural lens,and wherein the prosthetic capsular device is dimensioned to be at aposition that is at least one of substantially identical to, measurablydifferent than, and predictably different than the location of theposterior surface of the natural lens.

23. The method of any one of embodiments 14-22, further comprising,before inserting the prosthetic capsular device, forming an anteriorcapsulorhexis in natural capsular bag of the eye, wherein inserting theprosthetic capsular device is through the anterior capsulorhexis.

24. The method of any one of embodiments 14-23, wherein the prostheticcapsular device includes an exterior contour configured to mechanicallymaintain the prosthetic capsular device at a specific position withinthe eye.

25. The method of any one of embodiments 14-24, wherein the technologydevice is configured to control at least one of the following propertiesof the prosthetic capsular device: light transmission, UV transmission,and heat insulation.

26. A prosthetic capsular device for insertion into an eye holding atechnology device.

27. A prosthetic capsular bag or capsular enclosing device, forinsertion into the eye, which holds a miniaturized wearable electronictechnology device.

28. A prosthetic capsular device for insertion into an eye, theprosthetic capsular device comprising:

-   -   an anterior surface including an opening;    -   a posterior surface, at least a portion of the posterior surface        comprising a refractive surface; and    -   an external surface comprising form-fitting elements.

29. The prosthetic capsular device of embodiment 28, wherein theform-fitting elements comprise a plurality of tabs.

30. The prosthetic capsular device of embodiment 29, wherein theplurality of tabs are substantially continuous along an outer rim of theexternal surface.

31. The prosthetic capsular device of any one of embodiments 29 and 30,wherein at least one of the tabs comprises an opening through whichfibrosis can take place.

32. The prosthetic capsular device of any one of embodiments 29 and 30,wherein each of the tabs comprises an opening through which fibrosis cantake place.

33. The prosthetic capsular device of any one of embodiments 28-32,wherein the form-fitting elements comprise at least one of silicone,silicone derivatives, acrylic, acrylic derivatives, PMMA, olefin,polyimide, and collamer.

34. The prosthetic capsular device of any one of embodiments 28-33,further comprising an internal lip or sulcus configured to securehaptics of an intraocular lens in the device.

While the methods and devices described herein may be susceptible tovarious modifications and alternative forms, specific examples thereofhave been shown in the drawings and are herein described in detail. Itshould be understood, however, that the invention is not to be limitedto the particular forms or methods disclosed, but, to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the various implementationsdescribed and the appended claims. Further, the disclosure herein of anyparticular feature, aspect, method, property, characteristic, quality,attribute, element, or the like in connection with an implementation orembodiment can be used in all other implementations or embodiments setforth herein. Any methods disclosed herein need not be performed in theorder recited. The methods disclosed herein may include certain actionstaken by a practitioner; however, the methods can also include anythird-party instruction of those actions, either expressly or byimplication. For example, actions such as “inserting an intraocular lensinto a prosthetic capsular device” include “instructing the insertion ofan intraocular lens into a prosthetic capsular device.” The rangesdisclosed herein also encompass any and all overlap, sub-ranges, andcombinations thereof. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “about” or “approximately” includethe recited numbers and should be interpreted based on the circumstances(e.g., as accurate as reasonably possible under the circumstances, forexample ±5%, ±10%, ±15%, etc.). For example, “about 3.5 mm” includes“3.5 mm.” Phrases preceded by a term such as “substantially” include therecited phrase and should be interpreted based on the circumstances(e.g., as much as reasonably possible under the circumstances). Forexample, “substantially constant” includes “constant.”

What is claimed is:
 1. A method of operating on an eye, the methodcomprising: inserting a prosthetic capsular device in the eye, theprosthetic capsular device including: an anterior surface including anopening, and a posterior surface, at least a portion of the posteriorsurface comprising a refractive surface; inserting an electronic devicein the prosthetic capsular device; and inserting an intraocular lens inthe prosthetic capsular device, wherein after inserting the intraocularlens the electronic device does not interfere with sight lines throughthe intraocular lens, wherein the electronic device is configured toelectronically control from within the prosthetic capsular device aproperty of the intraocular lens.
 2. The method of claim 1, wherein theelectronic device is a computer, a virtual reality device, a displaydevice, an internet access device, a receiver, a game device, an imageviewer, a projector, a global positioning system, an e-mail device, or abiometric sensor device.
 3. The method of claim 1, wherein thecontrolled property of the intraocular lens includes at least one of:refractive capabilities, light transmission, UV transmission, oraccommodation properties.
 4. The method of claim 3, wherein theelectronic device forms an integral part of the intraocular lens, andwherein the electronic device surrounds all or part of an outerperimeter edge of the intraocular lens.
 5. The method of claim 1,wherein the electronic device comprises a power source capable of beingrecharged from outside the eye.
 6. The method of claim 1, whereininserting the prosthetic capsular device comprises inserting theprosthetic capsular device in a natural capsular bag of the eye.
 7. Themethod of claim 6, further comprising, before inserting the prostheticcapsular device, removing a natural lens from the natural capsular bag,the natural lens including a posterior surface at a location in thenatural capsular bag before removing the natural lens, and wherein theprosthetic capsular device is dimensioned to be at a position that isone of substantially identical to, measurably different than, orpredictably different than the location of the posterior surface of thenatural lens.
 8. The method of claim 1, further comprising, beforeinserting the prosthetic capsular device, forming an anteriorcapsulorhexis in natural capsular bag of the eye, wherein inserting theprosthetic capsular device is through the anterior capsulorhexis.
 9. Themethod of claim 1, wherein the prosthetic capsular device includes anexterior contour configured to mechanically maintain the prostheticcapsular device at a specific position within the eye.
 10. The method ofclaim 1, wherein the prosthetic capsular device comprises an insulationstructure configured to thermally insulate the eye from heat produced bythe electronic device in the housing structure.
 11. The method of claim1, wherein the prosthetic capsular device protects the eye fromelectromagnetic waves generated by the electronic device.
 12. The methodof claim 1, wherein the electronic device comprises: an intraocularpressure sensor; and a power source.
 13. The method of claim 1, whereinthe electronic device comprises a biometric measurement device.
 14. Themethod of claim 13, wherein the biometric measurement device comprisesan intraocular pressure sensor.
 15. The method of claim 13, wherein thebiometric measurement device comprises a glucose level sensor.
 16. Themethod of claim 12, wherein the electronic device further comprises awireless transmitter, wherein the electronic device is configured tocollect data from the biometric measurement device and to wirelesslytransmit the data using the wireless transmitter.
 17. The method ofclaim 1, wherein the electronic device is configured to surround anouter edge of the refractive surface.
 18. The method of claim 1, whereinthe electronic device comprises a projector.
 19. The method of claim 1,wherein the electronic device comprises: a biometric measurement device,a power source, a processor, and a wireless transmitter.
 20. The methodof claim 19, further comprising accessing data from the electronicdevice inserted in the prosthetic capsular device in the eye.
 21. Themethod of claim 20, wherein accessing the data comprises collecting datafrom a signal transmitted by the wireless transmitter.
 22. The method ofclaim 20, wherein, before accessing the data, the data is transformed bythe processor.
 23. The method of claim 20, wherein accessing the data isusing a smart device.
 24. The method of claim 23, wherein the smartdevice comprises a smart phone or a smart watch.
 25. The method of claim23, further comprising, after accessing the data, the data istransformed on the smart device.
 26. The method of claim 25, wherein thetransformed data is in a format usable in a health care decision. 27.The method of claim 1, further comprising accessing data from theelectronic device inserted in the prosthetic capsular device in the eye.